The benefit of surgical resection in addition to systemic therapy in patients with gastric/gastroesophageal cancer and peritoneal metastases (GCPM) is controversial. This CONVERGENCE trial aims to study the potential benefits of conversion surgery in patients with peritoneal metastases. This is a prospective, pragmatically designed, multicentre, randomized, investigator-initiated phase II/III trial. Patients with synchronous GCPM who have undergone either systemic therapy (including 1 L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy with favourable response would be randomized in 1:1 ratio to Arm 1 (Conversion surgery followed by systemic +/- peritoneal directed chemotherapy or Arm 2 (continual systemic +/- peritoneal directed chemotherapy). In the initial Phase II trial, 136 patients will be recruited and randomized. The primary endpoint is overall survival; main secondary endpoints include progression-free survival, R0 resection and complete cytoreduction rates, surgical morbidity/mortality and quality of life outcomes. If pre-defined thresholds of improved overall survival are met, the trial will expand to adequately power a phase III randomized controlled trial (n = 300). If survival benefit in conversion gastrectomy is demonstrated, this could potentially be a new standard of care for patients with peritoneal metastases from gastric or gastroesophageal junction cancer. Conversely, negative findings may lead to the avoidance of unnecessary surgical procedures and morbidity in these patients. NCT07241715.
OBJECTIVE:To determine the impact of severity of esophageal anastomotic leak (AL), standardized by ECCG grading, on long-term survival within a contemporary multicenter cohort. SUMMARY BACKGROUND DATA:Historical evidence suggesting AL is associated with increased recurrence and poor survival is limited by heterogeneous definitions and outdated management. This study utilizes the standardized ECCG definition to evaluate the prognostic significance of AL severity under modern perioperative protocols and endoscopic rescue strategies. METHODS:An international multicenter cohort across 17 high-volume European centers. Adult patients with esophageal or junctional cancer treated with neoadjuvant CROSS or FLOT, followed by esophagectomy were included (2018-2023). RESULTS:Out of 2905 patients, 425 (14.6%) developed an AL. AL was associated with a nearly two-fold increase in pulmonary complications (46.8% vs. 26.7%; P<0.001). AL requiring surgical reintervention (type III) was associated with an increased 30- and 90-days mortality rate (7.3% vs. 2.7% and 12.3% vs. 4%, P<0.001) and a significant reduction in median overall survival versus the no leak group (33.9 vs. 69.3; months P<0.001). After multivariable adjustment, type III AL was associated with a greater likelihood of death (HR 1.51; 95% CI: 1.04-2.18; P=0.029). A lower rate of adjuvant therapy administration (33.9% vs. 43.3%; P=0.004) was observe for AL patients. No significant survival deficits were observed for leaks treated conservatively or with no-surgical intervention. CONCLUSIONS:AL requiring surgical reintervention was associated with impaired survival. This relationship identifies a high-risk clinical profile and represents a critical target for future research into strategies for clinical stabilization and risk mitigation.
INTRODUCTION:Resection of intraductal papillary mucinous neoplasm (IPMN) aims to prevent progression to invasive pancreatic cancer. However, the risks of pancreatic surgery and frequent findings of low-grade dysplasia (LGD) raise concerns about overtreatment. This EAHPBA-endorsed multinational study evaluated short- and long-term overall survival (OS) following preventive resection for IPMN (without pre-operative signs of cancer). METHODS:Adult patients with resected IPMN showing LGD, high grade dysplasia (HGD) or T1-staged invasive carcinoma from 2008-2023 were identified from the OPTIMAL-IPMN database. Estimated OS rates at one, five and 10 years in patients undergoing preventive pancreatic resection were assessed using Kaplan-Meier analyses and predictors for mortality were evaluated using parametric survival regressions. RESULTS:Among 2275 patients in the OPTIMAL-IPMN database, 1728 (77%) had undergone preventive pancreatic resection for IPMN. Of those were 61% resected without prior surveillance. Final pathology revealed LGD in 63%, HGD in 27% and T1a-c-staged invasive cancer in 10% (7.3% T1a-b, 2.8% T1c). Estimated 1-year OS rate was 97%. Estimated 5-year OS rates (landmark analysis at 1 year) for LGD, HGD, T1a-b, and T1c was 97%, 99%, 96% and 91% respectively. Independent predictors for long-term mortality included age ≥ 75 versus < 75 years (HR 1.97) and T1c versus LGD (HR 8.12). CONCLUSION:This multinational study confirms excellent survival after preventive IPMN resection but reveals many upfront resections yielding LGD with unknown survival benefit. Future studies should aim to determine which patients can be followed safely with monitoring to avoid unnecessary immediate resection.
BACKGROUND:In expert centres, surgical resection rates for patients with locally advanced pancreatic cancer (LAPC) after induction chemotherapy have increased beyond 20% with subsequent 25% 5-year overall survival (OS). In the Netherlands, however, the historical low 8% LAPC resection rate compared with 23% in international expert centres reflects a relative reluctance to perform resections. Thereby, opportunities to achieve long-term survival in appropriately selected patients may be missed. The aim of this study was to evaluate whether nationwide implementation of international multidisciplinary best practice for LAPC management is feasible while maintaining surgical safety benchmarks (in-hospital/30-day major morbidity <50% and mortality ≤5%). METHODS:A multidisciplinary protocol was designed in collaboration with four international experts and prospectively implemented nationwide within the Dutch Pancreatic Cancer Group (DPCG) (2022-2024). This observational cohort included consecutive patients diagnosed with LAPC, defined by DPCG criteria. Eligible patients had radiologically non-progressive disease after ≥4 months of multiagent chemotherapy. All patients who underwent resection were included in this safety analysis. A predefined subgroup analysis included patients with National Comprehensive Cancer Network (NCCN) LAPC. Primary outcomes included in-hospital/30-day major morbidity (that is Clavien-Dindo grade ≥IIIa) and mortality. The expected number of resections was 53. RESULTS:Overall, 180 patients with LAPC underwent surgical exploration, of whom 155 (86%) underwent resection in 11 centres. Most resections (74%) were performed in the three LAPC surgical centres. An extended resection was performed for 77% of patients, including portomesenteric venous (60%), multivisceral (23%), and arterial (21%) resections. The in-hospital/30-day major morbidity rate was 44% and the mortality rate was 0.6%, both within pre-established safety benchmarks. Benchmarks were also reached for patients with NCCN LAPC (49% major morbidity and 2% mortality). CONCLUSION:Nationwide implementation of the international best practice for LAPC was feasible with nearly three times more resections performed than expected, while morbidity and mortality remained well within predefined safety benchmarks.
Background The peritoneum is a common metastatic site in gastric cancer. The prognosis of synchronous peritoneal metastases compared to other metastatic sites in gastric cancer remains understudied. This study aims to evaluate the impact of peritoneal metastases on survival in patients with metastatic gastric cancer. Methods Patients with gastric cancer and synchronous metastases between 2015 and 2020 were identified from the nationwide Netherlands Cancer Registry. Patients were categorized based on the site of metastases. Median overall survival (OS) was calculated for each metastatic site group. Multivariable Cox regression analyses were performed to evaluate the association between patient, tumour, and treatment characteristics, including the impact of systemic therapy, on OS. Findings A total of 4072 patients were included, of whom 1835 (45.1%) had peritoneal metastases. Of these, 58.1% had isolated peritoneal metastases. For patients with metastatic gastric cancer treated with systemic therapy, the median OS was 9.0 months (95% confidence interval (CI): 8.6-9.5), compared to 1.7 months (95% CI: 1.7-1.9) for treatment-na & iuml;ve patients, who received only palliative care. The survival for patients with isolated peritoneal metastases (4.4 months, 95% CI: 4.0-4.8 months) was similar to those with isolated non-peritoneal metastases (4.6 months, 95% CI: 4.2-5.1 months, adjusted HR: 0.94, 95% CI: 0.86-1.03, p = 0.185). Systemic therapy was associated with comparable survival in patients with peritoneal metastases and those with metastases at other sites. Interpretation This study demonstrates that there is no statistically significant difference in survival between patients with isolated peritoneal metastases and those with isolated non-peritoneal metastases in gastric cancer. Our findings emphasize the unique prognostic landscape for peritoneal metastases in gastric cancer, underscoring the need for disease-specific evaluations, rather than relying on assumptions derived from other cancer types.
BACKGROUND:Postoperative pancreatic fistula represents the leading cause of morbidity and mortality after robotic pancreatoduodenectomy. Various scores have been proposed to stratify patients based on their postoperative pancreatic fistula risk, including three fistula risk scores, and two International Study Group for Pancreatic Surgery scores. This study compares the performance of these scores in patients undergoing robotic pancreatoduodenectomy. METHODS:This is a multicentre European retrospective study in consecutive patients receiving robotic pancreatoduodenectomy for all indications (April 2014 to December 2021). The performance of the International Study Group for Pancreatic Surgery 4-tier (A-D) risk score, and its 3-tier (A-C) modification (International Study Group for Pancreatic Surgery 3-tier), fistula risk scores, alternative-fistula risk scores and the updated alternative-fistula risk scores in postoperative pancreatic fistula grade B/C prediction were compared based on their discrimination (area under the curve), calibration and clinical utility, evaluated through decision curve analyses. RESULTS:Overall, 919 patients undergoing robotic pancreatoduodenectomy were included. The rate of grade B/C postoperative pancreatic fistula was 22.2% (n = 204). The area under the curve for the five scores differed only slightly: International Study Group for Pancreatic Surgery 0.63 (95% confidence interval (c.i.) 0.58 to 0.67), International Study Group for Pancreatic Surgery 3-tier 0.63 (95% c.i. 0.58 to 0.67), fistula risk scores 0.65 (95% c.i. 0.61 to 0.69), alternative-fistula risk scores 0.64 (95% c.i. 0.60 to 0.68) and updated alternative-fistula risk scores 0.65 (95% c.i. 0.60 to 0.69). The International Study Group for Pancreatic Surgery, International Study Group for Pancreatic Surgery 3-tier, fistula risk scores and alternative-fistula risk scores underestimated the risk of postoperative pancreatic fistula. In contrast, the updated alternative-fistula risk score was well-calibrated at low predicted risks, but overestimated postoperative pancreatic fistula risk for high-risk patients. In decision curve analyses, the updated alternative-fistula risk score showed a higher clinical utility compared with the four other risk scores. CONCLUSION:The clinical utility of the updated alternative-fistula risk score for robotic pancreatoduodenectomy slightly outperformed the four other fistula risk scores, and might be used for patient counselling and patient stratification in clinical practice and research.
Objective: To identify learning curves for robotic gastroenterostomy (RGE) during robotic pancreatoduodenectomy (RPD) and the predictive value of the objective structured assessment of technical skills (OSATS) score for delayed gastric emptying (DGE) according to the Birkmeyer and colleagues and University of Pittsburgh Medical Center method. Background: In some series, RPD has been associated with an increased risk of DGE. It is unclear whether this is attributable to learning curve. Improved surgical performance and experience have not yet been linked to a decrease in DGE in RPD. Methods: Post hoc study of the prospective multicenter (LAELAPS-3) training program, including videos of RGE during RPD. Surgical performance was scored with OSATS by 2 blinded graders. The main outcomes are the combined OSATS scores of 2 blinded graders over time (learning curve). Secondary outcome is the correlation between OSATS scores and clinically relevant DGE (grade B/C). Results: Videos from 192 RGE anastomoses were included. DGE occurred in 42/192 (21.9%) patients. The mean OSATS score was 22.4 (SD ± 5.1) and predicted DGE Area under the curve (AUC): 0.668, P < 0.001). The predictive OSATS elements for DGE were gentleness (AUC: 0.719, P < 0.001), instrument handling (AUC: 0.595 P = 0.043), tissue exposure (AUC: 0.625, P = 0.009), and summary score (AUC: 0.665, P < 0.001). An OSATS score >25 was associated with a 59.9% reduced relative risk of grade B/C DGE [11.3% (8/71) vs 28.1% (34/121); odds ratio (OR): 0.325, P = 0.006]. Cumulative sum analysis of RGE-OSATS identified a turning point at 34 procedures [25.7% (36/140) before vs 11.5% (6/52) after; OR: 0.156, P = 0.035]. On multivariable analysis for grade B/C DGE, OSATS ≤25 remained an independent risk factor (OR: 2.907, P = 0.028). Conclusions: Better surgical performance during gastroenteric anastomosis in RPD, as assessed by OSATS, is associated with a reduced rate of grade B/C DGE. OSATS could serve as a tool for competency-based training programs and quality-controlled implementation of RPD.
The gold standard for evaluating the presence and extent of peritoneal lesions is determining the surgical peritoneal cancer index (PCI). However, there is a growing need for non-invasive methods to assess peritoneal lesions. While the standardised and quantified PCI scoring system can be applied to imaging, the region definitions used for surgical PCI assessment are not directly applicable to radiological assessment. To define region boundaries applicable to radiological PCI assessment. A Delphi study was conducted among 88 international experts, including radiologists, surgeons and gynaecologists. Within a questionnaire, the proposed regions for radiological PCI evaluation were shown as overlays on a CT scan and 3D volumes. Participants rated their level of agreement for each structure and region boundary on a 5-point Likert scale in iterative rounds. Consensus was defined as > 75
Background: Preoperative planning of patients diagnosed with pancreatic head cancer is difficult and requires specific expertise. This pilot study assesses the added value of three-dimensional (3D) patient models and computer-aided detection (CAD) algorithms in determining the resectability of pancreatic head tumors. Methods: This study included 14 hepatopancreatobiliary experts from eight hospitals. The participants assessed three radiologically resectable and three radiologically borderline resectable cases in a simulated setting via crossover design. Groups were divided in controls (using a CT scan), a 3D group (using a CT scan and 3D models), and a CAD group (using a CT scan, 3D and CAD). For the perceived fulfillment of preoperative needs, the quality and confidence of clinical decision-making were evaluated. Results: A higher perceived ability to determine degrees and the length of tumor–vessel contact was reported in the CAD group compared to controls (p = 0.022 and p = 0.003, respectively). Lower degrees of tumor–vessel contact were predicted for radiologically borderline resectable tumors in the CAD group compared to controls (p = 0.037). Higher confidence levels were observed in predicting the need for vascular resection in the 3D group compared to controls (p = 0.033) for all cases combined. Conclusions: “CAD (including 3D) improved experts’ perceived ability to accurately assess vessel involvement and supports the development of evolving techniques that may enhance the diagnosis and treatment of pancreatic cancer”.
BACKGROUND:Online video consultation between patients and health-care providers rapidly gained popularity during the COVID-19 pandemic. However, to our knowledge, there is no high-quality comparative evidence regarding patient satisfaction and quality of information recall with online video consultation and traditional face-to-face consultation. This lack of evidence is especially concerning in the most demanding consultations. We aimed to assess whether online video consultation between patients and surgeons before major abdominal surgery was non-inferior to face-to-face consultation in terms of patient satisfaction, and to assess effects on patient information recall. METHODS:This open-label, randomised, controlled, non-inferiority trial (VIDEOGO) was conducted at two hospitals (one academic and one regional) in the Netherlands. Adult patients (aged ≥18 years) who required consultation with a surgeon to discuss major abdominal surgery and were able and willing to interact via both online video and face-to-face consultation were eligible for inclusion; patients were excluded if they were unable or unwilling to start or maintain online video consultation. Eligible patients were randomly allocated (1:1) to online video or face-to-face consultation by the study coordinator, using a computer-generated, concealed, permuted-block randomisation method with varying block sizes (two, four, and six patients), stratified by study site. Masking of patients and health-care providers was not possible owing to the nature of the study. The primary outcomes were patient satisfaction (score 0-100; assessed for non-inferiority with a predefined margin of -10%) and information recall (score 0-11), both of which were assessed with online questionnaires and analysed in the intention-to-treat population for whom outcome data were available. Technical adverse events were assessed directly after the consultation as part of the satisfaction questionnaire. This trial is registered with the International Clinical Trial Registry Platform and the Central Committee on Research Involving Human Subjects registry, NL-OMON20092, and is complete. FINDINGS:Between Feb 13, 2021, and Oct 2, 2023, 120 patients were randomly assigned: 60 to online video consultation and 60 to face-to-face consultation. Outcome data were available for 57 patients in the online video consultation group (20 [35%] female and 37 [65%] male; median age 64·0 [54·5-72·5] years) and 55 patients in the face-to-face group (22 [40%] female and 33 [60%] male; median age 62·0 [56·0-70·0] years). The mean patient satisfaction score was 85·4 out of 100 (SD 12·3) in the online video consultation group and 85·2 (14·2) in the face-to-face group (mean difference 0·2, 95% CI -4·8 to 5·1), which was within the non-inferiority margin of -10% (pnon-inferiority<0·0001). The mean information recall score was 7·30 out of 11 (SD 1·60) in the online video consultation group and 7·25 (1·48) in the face-to-face group (mean difference 0·05, 95% CI -0·53 to 0·63). Technical adverse events occurred for two (7%) of 29 patients for whom data were available: one patient experienced a problem with the video connection and one experienced a problem with audio, both of which were resolved during the consultation without affecting the conversation. INTERPRETATION:The use of online video consultation during surgical consultation for major abdominal surgery was non-inferior to face-to-face consultation in terms of patient satisfaction and did not substantially affect information recall. These findings suggest that online video consultation can be implemented confidently in surgical outpatient clinics. FUNDING:The Netherlands Organization for Health Research and Development.
BACKGROUND:Boerhaave syndrome is defined as a spontaneous perforation of the oesophagus. The mainstay of treatment is resuscitation of the patient, closure of the oesophageal defect, and drainage of perioesophageal and pleural fluid collections. Whether the optimal approach is endoscopic, surgical, or conservative management remains unknown and there are no clear guidelines. The aim of this multicentre retrospective cohort study was to evaluate current treatment strategies and outcomes for Boerhaave syndrome. METHODS:A multicentre retrospective analysis of data from 23 participating European tertiary centres was performed. Patients with Boerhaave syndrome treated between January 2019 and December 2023 were eligible for inclusion. The primary endpoint was the length of ICU stay and secondary endpoints included in-hospital mortality, 90-day mortality, and the length of overall hospital stay. RESULTS:In total, 216 patients were included; 151 were men (70%), the median age was 62 (22-95) years, and 81 (40%) were treated >24 h after the start of symptoms. Seventy (32%) patients were managed endoscopically (group I), 73 (34%) were managed surgically (group II), 67 (31%) were managed using a combination of endoscopy and surgery (group III), and 6 (3%) were managed using other methods (group IV). For patients in groups I-III: the median length of ICU stay was 8 (0-67) days, with no differences between the three groups (P = 0.105); the in-hospital mortality rate and 90-day mortality rate were both 12% (P = 0.490 and P = 0.637, respectively); and the median length of overall hospital stay was 27 (range 1-193) days, with the longest stays observed in patients who received combined treatment (P = 0.032). CONCLUSION:This study provides a comprehensive overview of the current treatment strategies and outcomes for patients with Boerhaave syndrome in Europe.
Objective: To determine if video grading using Objective Structured Assessment of Technical Skills (OSATS) could estimate the risk of postoperative bile leak (BL) after robotic pancreatoduodenectomy (RPD) and to identify a learning curve effect. Summary Background Data: The hepaticojejunostomy (HJ) bile leak rate after RPD is rather high with 10% and may be improved by structured training and skills. Robotic HJ therefore requires confirmation of adequate performance. Grading of surgical performance during HJ could be used in competency-based surgical training. Methods: Post-hoc analysis of patients included the Dutch LAELAPS-3 RPD training program in 6 centers. Technical performance during robotic HJ was graded by two blinded graders using OSATS (attainable scores 6-30). Primary outcome was grade B/C bile leak according to the ISGLS. Logistic regression determined the performance cut-off and CUSUM analysis identified the learning curve. Results: Videos from robotic HJ in 259 patients were included with a 6.9% rate of grade B/C bile leak (n=18/259). The median OSATS for the HJ was 25.0 [22–27], with an OSATS score>21 associated with a reduced risk of BL. The rate of BL was 5.1% in patients for OSATS>21 and 12.5% for OSATS ≤21, amounting to a relative reduction of 59.2% and an absolute reduction of 7.4% (8/64 vs. 10/195, OR 0.378, P =0.013). These findings remained similar when only including grade C BL: OR 0.076, P =0.004. On multivariable analysis for grade B/C BL, the only significant predictive factor was OSATS>21: OR 0.273, P =0.025. Stabilization of the CUSUM learning curve for grade B/C BL was reached at 19 RPD procedures, and after 44 procedures the learning curve showed a continuous downward trend. The rate of grade B/C BL was significantly lower beyond 19 RPD: 5.6% versus 8.6% (8/143 vs. 10/116, OR 0.710, P =0.040). Conclusions: The risk of postoperative BL after RPD is strongly associated with surgical performance during robotic HJ as objectified using OSATS. This approach can be used for rapid assessment of the learning curve and competency-based surgical training, aiming for a safe implementation RPD.
BACKGROUND:Peritoneal metastases of gastric cancer are associated with a poor prognosis (median overall survival (OS) ∼9 months). Catheter-based intraperitoneal (CBIP) chemotherapy is a locoregional approach to deliver chemotherapy leading to higher intraperitoneal (IP) concentrations of cytotoxic drugs compared to intravenous administration. METHOD:This multicenter, open-label 3 + 3 + 3 dose-escalation phase I trial evaluated 3-weekly IP irinotecan with oral capecitabine and intravenous oxaliplatin (CAPOX). Patients with HER2-negative gastric cancer and macroscopic peritoneal metastases were included. IP irinotecan was administered on day 1 of a 3-weekly cycle. The primary objective was to establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs). Secondary endpoints included safety, the pharmacokinetic profile of IP irinotecan, and clinical efficacy. RESULTS:A single DLT occurred in six patients in both the 50 mg and the 75 mg dose cohort. Two DLTs were observed in the three patients in the 100 mg dose cohort, estimating 75 mg IP irinotecan as the MTD. Treatment was well tolerated, with primarily low-grade adverse events, including gastrointestinal toxicity, bone marrow suppression, and peripheral neuropathy. The exposure to the active metabolite SN-38 was higher intraperitoneally than systemically (ratio of 2.1, range: range: 0.9-7.4). The median OS was 11.8 months (95 % CI: 5.5-18.0 months). CONCLUSION:Administration of 3-weekly CBIP irinotecan concomitant to systemic CAPOX was well tolerated at 75 mg in patients with gastric cancer and peritoneal metastases. Giving its promising clinical outcomes and the safety profile, CBIP of irinotecan provides a potential new treatment modality. A phase II study will commence to assess its feasibility and efficacy.
Importance:The DIPLOMA trial showed comparable radical resection rates after minimally invasive left pancreatectomy (MILP) and open left pancreatectomy (OLP) in patients with upfront resectable pancreatic cancer. Data on long-term overall survival (OS) and disease-free survival (DFS) are currently lacking, but are required before the oncological efficacy of MILP can be confirmed. Objective:To determine the long-term oncological outcome, including OS and DFS, of MILP vs OLP in patients with upfront resectable left-sided pancreatic cancer in the DIPLOMA trial. Design, Setting, and Participants:The randomized, patient-blinded and pathologist-blinded DIPLOMA trial was conducted between 2018 and 2021, with a follow-up duration of at least 36 months. It was a multicenter international trial that took place in 35 centers in 12 countries worldwide. Patients with upfront resectable pancreatic ductal adenocarcinoma of the body or tail of the pancreas were included. Interventions:Participants were randomly assigned to undergo MILP (laparoscopic and robotic) or OLP. Patients were blinded for the surgical approach. Main Outcomes and Measures:Main outcomes included OS and DFS. Other outcomes include receipt of adjuvant therapy and time to start of adjuvant therapy. Results:Between May 2018 and May 2021, 258 patients were randomized to the MILP (131 patients) and OLP (127 patients) groups. After a median follow-up of 38 (IQR 36-46) months, 134 patients (52%) had died and 127 patients (55%) experienced disease recurrence. OS did not differ significantly between the MILP and OLP groups (median, 32 vs 34 months; stratified hazard ratio, 1.02; 95% CI, 0.72-1.44; P = .92). Also, DFS did not significantly differ between the MILP and OLP groups (median, 21 vs 17 months; stratified hazard ratio, 0.96; 95% CI, 0.68-1.35; P = .81). Adjuvant therapy was administered in 79 patients after MILP (79 of 113 [70%]) and 79 patients after OLP (79 of 110 [72%]) (P = .63). Time to adjuvant therapy was comparable between groups (median 59 vs 56 days; P = .92). Conclusions and Relevance:In this long-term follow-up of the randomized DIPLOMA trial in patients with upfront resectable pancreatic cancer, oncological outcomes after MILP and OLP did not differ significantly, confirming the oncological safety of MILP. Trial Registration:International Standard Registered Clinical/Social Study Number Registry Identifier: ISRCTN44897265.
Background: Ampullary adenocarcinoma (AAC) typically presents at an early stage due to biliary obstruction and therefore might be specifically suitable for minimally invasive pancreatoduodenectomy (MIPD). However, studies assessing MIPD specifically for AAC, including the robotic and laparoscopic approach, are limited. The aim of this study is to compare short- and long-term oncological resection and perioperative outcomes of robotic (RPD), laparoscopic (LPD) and open pancreatoduodenectomy (OPD) performed specifically for AAC. Methods: In this multicenter international cohort study, encompassing 35 centers from 11 countries, MIPD versus OPD and subgroup analyses of LPD versus RPD were undertaken. The primary outcomes regarded the oncological resection (R1 resection rate, lymph node yield) and 5-years overall survival. Secondary outcomes were perioperative outcomes (including intra-operative variables, surgical complications and hospital stay). Results: In total, patients with AAC who underwent OPD (1721) or MIPD (141) were included. After propensity-score matching, 134 patients per cohort were included. The MIPD group consisted of 53 RPDs and 71 LPDs (50 per group after PSM). There was no difference in overall survival between MIPD and OPD (61.6 % vs 56.2 %, P = 0.215). In the MIPD group, operative time was longer (439 vs 360 min, P < 0.001). Between RPD and LPD, overall survival was not significantly different (75.8 % vs 47.4 %, P = 0.098) and lymph node yield was higher in RPD (21 vs 18, P = 0.014). Conclusion: In conclusion, patients with AAC seem to have comparable oncological resection and perioperative outcomes from MIPD compared to the traditional OPD. Both RPD as LPD appear to be safe alternatives for patients with AAC, which warrants confirmation by future randomized studies.
Introduction: The incidence of adhesive small bowel obstruction (ASBO) after abdominal surgery is 2.4%. Delay in surgery increases morbidity and mortality. Plasma intestinal fatty acid binding protein (I-FABP) levels indicate intestinal damage and may guide treatment. The aim of this study was to investigate whether plasma I-FABP levels may optimize selection of patients requiring surgery presenting with ASBO. METHODS:Patients with suspected ASBO underwent a contrast swallow. If bowel transit was absent after 8 h, surgery was performed. I-FABP levels were assessed at several moments. Data were analyzed by comparing groups based on bowel transit, ischemia, and positive or negative laparotomies. Furthermore, a true operative group (patients with mechanical obstruction during surgery and patients needing operative treatment who deceased due to non-operative treatment) was compared to a true non-operative group (patients with negative laparotomies and patients successfully treated with non-operative treatment). RESULTS:Median I-FABP levels were higher in patients without bowel transit (1,207 pg/mL) than in patients with bowel transit (589 pg/mL, p = 0.01). Median I-FABP levels in the negative laparotomy group (301 pg/mL) showed a trend to significance compared to the positive laparotomy group (1,177 pg/mL, p = 0.05). There was no significant difference between the true operative group (1,150 pg/mL) and the true non-operative group (664 pg/mL) or between proven ischemia (975 pg/mL) and no ischemia (921 pg/mL). CONCLUSION:I-FABP might help identify ASBO patients in whom surgery can be postponed. .
In patients with resectable pancreatic and periampullary neoplasm, MIPD was noninferior to OPD for 90-day overall complications (Funded by Intuitive Surgical and Fondazione Poliambulanza Istituto Ospedaliero; International Standard Randomised Controlled Trial Number Registry, ISRCTN27483786.).
OBJECTIVE:To compare the quality of recovery in patients receiving epidural or paravertebral analgesia for minimally invasive esophagectomy (MIE). BACKGROUND:Paravertebral analgesia may be a promising alternative to epidural analgesia, avoiding potential side effects and improving postoperative recovery. METHODS:This randomized controlled superiority trial was conducted across 4 Dutch centers with esophageal cancer patients scheduled for transthoracic MIE with intrathoracic anastomosis, randomizing patients to receive either epidural or paravertebral analgesia. The primary outcome was Quality of Recovery (QoR-40) on the third postoperative day (POD). Secondary outcomes included quality of life, postoperative pain, opioid consumption, inotropic/vasopressor medication use, hospital stay, complications, readmission, and mortality. RESULTS:From December 2019 to February 2023, 192 patients were included: 94 received epidural and 98 paravertebral analgesia. QoR-40 score on POD3 was not different between groups (mean difference: 3.7, 95% CI: -2.3 to 9.7; P =0.268). Epidural patients had significantly higher QoR-40 scores on POD1 and 2 (mean difference: 7.7, 95% CI: 2.3-13.1; P =0.018 and mean difference: 7.3, 95% CI: 1.9-12.7; P =0.020) and lower pain scores (median 1 vs 2; P <0.001 and median 1 vs 2; P =0.033). More epidural patients required vasopressor medication on POD1 (38.3% vs 13.3%; P <0.001). Urinary catheters were removed earlier in the paravertebral group (median POD3 vs 4; P <0.001). No significant differences were found in postoperative complications or hospital/intensive care unit stay. CONCLUSIONS:This randomized controlled trial did not demonstrate the superiority of paravertebral over epidural analgesia regarding the quality of recovery on POD3 after MIE. Both techniques are effective and can be offered in clinical practice.
The success of deep learning and computer vision of natural images has led to an increased interest in medical image deep learning applications. However, introducing black-box deep learning models leaves little room for domain-specific knowledge when making the final diagnosis. For medical computer vision applications, not only accuracy, but also robustness, interpretability and explainability are essential to ensure trust for clinicians. Medical deep learning applications can therefore benefit from insights into the application at hand by involving clinical staff and considering the clinical diagnostic process. In this review, different clinically-inspired methods are surveyed, including clinical insights used at different stages of deep learning design for three-dimensional (3D) computed tomography (CT) image data. This review is conducted by investigating 400 research articles, covering different deep learning-based approaches for diagnosis of different diseases, in terms of including clinical insights in the published work. Based on this, a further detailed review is conducted of the 47 scientific articles using clinical inspiration. The clinically-inspired methods were found to be made with respect to preparation for training, 3D medical image data processing, integration of clinical data and model architecture selection and development. This highlights different ways in which domain-specific knowledge can be used in the design of deep learning systems.