Background Endoscopic ultrasound-guided hepatico-gastrostomy (EUS-HGS) enables internal biliary drainage via the stomach in patients with altered anatomy, inadequate left hepatic duct drainage, or duodenal obstruction. The technically demanding procedure is only performed at expert centers in the Netherlands. Most available evidence originates from selected cohorts, overestimating real-world outcomes. We evaluated outcomes of EUS-HGS in a nationwide cohort. Methods This nationwide retrospective cohort study included all patients in the Netherlands who underwent EUS-HGS attempts between 2009 and 2025, outside of prospective studies. The primary outcome was technical success. Secondary outcomes included clinical success, complications, time to recurrent biliary obstruction (RBO), and overall survival. Results A total of 107 procedures in 105 patients were analyzed (median age: 68 years [IQR: 59-76]; 55%: male). Technical success was achieved in 77% (81/105). Failures were due to absence of a safe puncture tract (n = 7), unsuccessful bile duct puncture (n = 3), inability to achieve deep guidewire insertion (n = 3), failed fistula formation (n = 3), or unsuccessful or non-attempted stent placement (n = 7). Clinical success occurred in 78% of technically successful cases (63/81), corresponding to 60% in intention-to-treat analysis (63/105). Procedural complications occurred in 16/107 (15%), and postprocedural complications in 17/107 (16%). One procedure-related death occurred. RBO occurred in 28% (23/81) during a median follow-up of 61 days [IQR: 23-131]. Median overall survival was 91 days [IQR: 66-155]. Conclusion In this nationwide real-world cohort, technical and clinical success rates of EUS-HGS were modest compared with selected expert series, underscoring the need for prospective studies to improve patient selection, stent strategies, and procedural safety.

Background and study aims:Effective strategies to prevent delayed bleeding (DB) following endoscopic mucosal resection (EMR) for large superficial non-ampullary duodenal tumors (SNADTs) remain limited. Octreotide exerts pharmacological effects that may influence hemostasis and thereby reduce bleeding risk. This exploratory study aimed to evaluate the association between postprocedural octreotide use and DB after duodenal EMR for large SNADTs. Patients and methods:This single-center, exploratory, retrospective study included all hot EMRs for large SNADTs ≥ 10 mm (2015-2024). Routine post-procedural intravenous octreotide (50 μg/h) was introduced in 2022, administered immediately post-EMR at 50 μg/hour during overnight observation. DB was defined as clinically significant bleeding within 30 days requiring prolonged hospitalization, readmission, or intervention. Results:A total of 107 SNADTs (median diameter 25 mm; interquartile range 15-40) were resected, including 33 treated with octreotide. Overall, DB occurred in 20% of patients (21/107), including 24% (18/74) in the control group and 9% (3/33) in the octreotide group. In logistic regression adjusting for lesion size and propensity score, octreotide showed a non-significant trend toward reduced DB overall (odds ratio [OR] 0.34; 95% confidence interval [CI] 0.08-1.17; P = 0.11). In the subgroup of lesions ≥ 30 mm, octreotide use was associated with a significantly lower odds of DB (OR 0.21; 95% CI 0.039-0.89; P = 0.045), whereas this association was not observed in smaller lesions. Conclusions:In this exploratory study, postprocedural intravenous octreotide appeared to be associated with a lower occurrence of DB after EMR for large SNADTs (≥ 30 mm). Larger, prospective studies are warranted to confirm these findings.

BACKGROUND:Endoscopic intermuscular dissection (EID) is a promising new technique for managing rectal deep submucosal invasive cancer (D-SMIC), but long-term outcome data are currently lacking. OBJECTIVE:This multicentre study evaluated the three-year oncological outcomes of EID, focusing specifically on patients with rectal D-SMIC who underwent active surveillance following the procedure. DESIGN:Data from consecutive, prospectively recorded EID procedures for suspected rectal D-SMIC-based on optical diagnosis-performed at two academic centres between 2019 and 2023 were analysed. D-SMIC was defined as submucosal invasion of sm2-sm3 depth. Histological risk factors included poorly differentiated tumours (G3), lymphovascular invasion, high-grade tumour budding and positive or indeterminate resection margins (R1/Rx). Study outcomes included three-year rates of locoregional recurrence (intramural and nodal), distant recurrence (metastatic disease), non-salvageable recurrence, cancer-specific mortality and secondary rectal surgery. Cumulative incidence was estimated using the Aalen-Johansen method. RESULTS:Among the 188 included cases, EID achieved an en bloc resection rate of 94.1% and R0 resection rate of 82.5%, respectively. Of the 177 procedures that were completed, 16% showed non-invasive histology (low-grade dysplasia/high-grade dysplasia; 20/177=11%) or superficial submucosal invasive cancer (sm1, 9/177=5%), and 31% (54/177) showed deeper (≥pT2) invasion. The remaining 94 D-SMIC cases (53%) represented the main target group. Of these, 37% (n=35) were classified as low risk (no histological risk factors), 34% (n=32) as intermediate risk (one risk factor) and 29% (n=27) as high risk (≥2 risk factors). Active surveillance was initiated in all low-risk patients, in 72% of the intermediate-risk cases and in 22% of the high-risk group. The remaining patients underwent completion surgery or adjuvant chemoradiotherapy. At three years, locoregional recurrence occurred in 7% (1/35, 95% CI 1% to 28%) of low-risk and 13% (2/15, 95% CI 2% to 35%) of intermediate-risk patients managed with active surveillance. All were successfully salvaged. Among the six high-risk patients under surveillance, locoregional recurrence was seen in two. No distant recurrences or cancer-specific deaths occurred in any D-SMIC group. Secondary rectal surgery was finally performed in 5.3%, 25.0% and 59.6% of the low, intermediate and high-risk groups, respectively. CONCLUSION:Despite the challenges associated with accurate preoperative staging, EID followed by active surveillance may offer a viable alternative to radical surgery for patients with low- and intermediate-risk rectal D-SMIC, avoiding rectal surgery in most cases while maintaining oncological safety.

BACKGROUND AND AIMS:The indication for primary surgery on suspected deep submucosal invasive colorectal carcinoma (d-SMIC) is debatable. Consequently, local excision techniques, such as endoscopic submucosal dissection (ESD), are increasingly attempted in such patients. This study retrospectively evaluated the effectiveness of ESD in obtaining a free vertical margin (VM)-R0 in suspected d-SMIC compared with suspected superficial SMIC (s-SMIC). METHODS:ESDs for suspected T1 colorectal cancer (CRC) in treatment-naïve polyps were included between 2011 and 2022 in 5 European tertiary referral centers. Based on optical assessment, lesions were categorized into suspected d-SMIC or s-SMIC. Main outcomes were the VM-R0 rate, en bloc resection rate, and adverse event rate. An adjusted risk ratio for VM-R1 resections within the suspected d-SMIC group was calculated. RESULTS:In the suspected s-SMIC group (n = 1063), en bloc resection rate, VM-R0 rate, proportion of pT1 CRC, and adverse even rate were 90.5% (95% CI, 88-92), 90.6% (95% CI, 88-92), 18.0%, and 3.6% (IQR, 2-5), respectively. In the suspected d-SMIC group (n = 139), these values were 61.9% (IQR, 54-70), 55.4% (IQR, 47-63), 74.8%, and 5.8% (IQR, 2-10), respectively. Compared with suspected s-SMIC cases, the VM-R0 rate of suspected d-SMIC cases particularly decreased for pT1Sm2-3 (75.9% vs 55.7%). None of the investigated features (age, sex, polyp location, size, morphology, and Hiroshima classification) predicted a VM-R1 resection in suspected d-SMIC cases. CONCLUSIONS:ESD performed on polyps with suspected d-SMIC showed lower VM-R0 rates for pT1Sm2-3 cases compared with suspected s-SMIC cases. This should be taken into account when selecting the optimal resection technique for suspected d-SMIC cases.

Background Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk. Objective To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement. Design This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up. Results Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality. Conclusion This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement. Trial registration number NL5130.

ImportancePatients with painful chronic pancreatitis and a dilated pancreatic duct can be treated by early surgery or an endoscopy-first approach.ObjectiveTo compare long-term clinical outcomes of early surgery vs an endoscopy-first approach using follow-up data from the ESCAPE randomized clinical trial.Design, Setting, and ParticipantsBetween April 2011 and September 2018, 88 patients with painful chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach in 30 hospitals in the Netherlands collaborating in the Dutch Pancreatitis Study Group as part of the ESCAPE randomized clinical trial. For the present cohort study, long-term clinical data were collected after the initial 18-month follow-up. Follow-up was completed in June 2022, and data analysis was performed in June 2023.ExposurePatients with chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach.Main Outcomes and MeasuresThe primary end point was pain, assessed by the Izbicki pain score; secondary end points included patient-reported complete pain relief and satisfaction. Predefined subgroups included patients who progressed from endoscopy to surgery and those with ductal clearance obtained by endoscopy. Analysis was performed according to the intention-to-treat principle.ResultsIn this cohort study, 86 of 88 overall patients could be evaluated, with a mean (SD) follow-up period of 98 (16) months. Of 88 initial patients, 21 patients (24%) were female, and mean (SD) patient age was 61 (10) years. At the end of long-term follow-up, the mean (SD) Izbicki pain score was significant lower (33 [31] vs 51 [31]) in the early surgery group, as was the rate of patient-reported complete pain relief (14 of 31 patients [45%] vs 6 of 30 patients [20%]), compared to the endoscopy-first group. After the initial 18-month follow-up, 11 of 43 patients in the early surgery group (26%) underwent reinterventions vs 19 of 43 patients in the endoscopy-first group (44%). At the end of follow-up, more patients in the early surgery group were “very satisfied” with their treatment (22 of 31 patients [71%] vs 10 of 30 patients [33%]). Patients who progressed from endoscopy to surgery (22 of 43 patients [51%]) had significantly worse mean (SD) Izbicki pain scores (33 [31] vs 52 [24]) compared to the early surgery group and had a lower rate of complete pain relief (55% for early surgery vs 12% for endoscopy first). In the endoscopy-first group, patients with endoscopic ductal clearance had similar mean (SD) Izbicki pain scores as the remaining patients (49 [34] vs 53 [28]).Conclusions and RelevanceIn this cohort study evaluating long-term outcomes of the ESCAPE randomized clinical trial, after approximately 8 years of follow-up, early surgery was superior to an endoscopy-first approach in patients with painful chronic pancreatitis and a dilated main pancreatic duct in pain scores and patient satisfaction. Notably, patients who progressed from endoscopy to surgery had worse outcomes compared to patients undergoing early surgery, and obtaining endoscopic ductal clearance did not improve outcomes.

Background Delayed bleeding is the most common complication after endoscopic mucosal resection (EMR) of large colorectal polyps. Randomized controlled trials in high volume centers have suggested that prophylactic clipping of the resection defect reduces delayed bleeding in patients with a high risk for delayed bleeding. We aimed to evaluate the role of prophylactic clipping in reducing delayed bleeding in patients undergoing EMR for large, proximal, nonpedunculated polyps in daily clinical practice. Methods We performed a randomized controlled trial in 19 Dutch hospitals in patients referred for EMR of laterally spreading and sessile polyps ≥ 20 mm in the proximal colon. Patients were randomly assigned (1:1) into groups receiving or not receiving prophylactic clipping. The primary end point was delayed bleeding, and analyses were performed according to intention-to-treat analysis. The trial was registered at ClinicalTrials.gov (NCT03309683). Results Between May 2018 and December 2021, 356 patients with a median polyp size of 30 mm (interquartile range 25–40) in the proximal colon were randomized (177 to the prophylactic clipping group and 179 to the control group). Delayed bleeding occurred in 16 patients (9.0 %) receiving prophylactic clipping and 11 control patients (6.1 %; P = 0.30). No deaths were reported. Conclusions Prophylactic clipping did not reduce delayed bleeding in patients undergoing EMR for large laterally spreading and sessile polyps in the proximal colon in daily clinical practice.

Background:With the increasing complexity and prolonged duration of endoscopic retrograde cholangiopancreatography (ERCP) procedures, sedation shifted from conscious sedation with benzodiazepines to deep sedation with propofol. We assessed the technical success and adverse event rates of ERCP with deep versus conscious sedation. Methods:Consecutive patients treated with ERCP in the University Medical Center Utrecht over a 7-year period (2010-2016) were screened for eligibility. Gastroenterologist-administered conscious sedation with midazolam was used from 2010-2013, whilst anesthesiology-administered deep sedation with propofol was used from 2013-2016. Data were retrospectively collected from electronic medical records. Outcomes were technical success and procedure-related adverse events within 30 days after ERCP. Associations of sedation type with outcomes were analyzed in univariable and multivariable analyses. Results:A total of 725 patients were included: 336 (46%) with conscious sedation and 389 (54%) with deep sedation. Technical success was significantly higher when propofol-based sedation was used (317 [82%] vs. 252 [75%], P=0.034). Adverse events also occurred significantly more often in the propofol group (77 [20%] vs. 38 [11%], P=0.002), due to higher rates of post-ERCP cholangitis (21 [5%] vs. 8 [2%], P=0.039), and post-ERCP pancreatitis (29 [7%] vs. 11 [3%], P=0.014). After adjustment, propofol-based sedation remained significantly associated with technical success and adverse events, with odds ratios of 1.53 (95% confidence interval [CI] 1.05-2.21) and 1.95 (95% CI 1.25-3.04), respectively. Conclusion:Propofol-based sedation resulted significantly more often in technical success of ERCP compared with midazolam-based sedation, but adverse events were almost twice as common, with higher rates of post-ERCP pancreatitis and cholangitis.

Background and Aims: Endoscopic retrograde cholangiopancreatography (ERCP) with brush cytology is an important tool in the diagnosis of hepatobiliary malignancies. However, reported sensitivity of brush cytology is suboptimal and differs markedly per study. The aim of this study is to analyze the optimal technique of endobiliary brushing during ERCP. Methods: A systematic review and meta-analysis according was performed using Pubmed, Embase and Cochrane library, and reported reported according to the PRISMA guidelines. The intervention reported should involve ERCP, performed by the endoscopist with a comparison of different brushing techniques. The primary outcome was sensitivity for malignancy. Studies published up to December 2022 were included. Percutaneous techniques and cytological or laboratory techniques for processing of material were excluded. Bias was assessed using the Quadas-2 tool. Pooled sensitivity rates and Forest plots were analyzed for the primary outcome. Results: A total of 16 studies were included. Three studies reported on brushing before or after dilation of a biliary stricture. No improvement in sensitivity was found. Five studies reported on alternative brush designs. This did not lead to improved sensitivity. Seven studies reported on the aspiration and analysis of bile fluid, which resulted in a 16% increase in sensitivity (95% CI 4-29%). One study reported an increased in the number of brush passes to the stricture, providing an increase in sensitivity of 20%. Substantial heterogeneity between studies was found, both methodological and statistical. Conclusions: Increasing the number of brush-passes and sending bile fluid for cytology increases the sensitivity of biliary brushings during ERCP. Dilation before brushing or alternative brush designs did not increase sensitivity.

Radboudumc, Netherlands; Catharina Ziekenhuis, Netherlands; Ziekenhuis Bernhoven Locatie Oss, Netherlands; Maasstad Ziekenhuis, Netherlands; Universitair Medisch Centrum Utrecht, Netherlands; Amsterdam UMC Locatie AMC, Netherlands; Noordwest Ziekenhuisgroep, Netherlands; Jeroen Bosch Ziekenhuis, Netherlands; Meander Medisch Centrum, Netherlands; Elisabeth-TweeSteden Ziekenhuis, Netherlands; Maxima Medisch Centrum, Netherlands; Leids Universitair Medisch Centrum, Netherlands; Medisch Centrum Leeuwarden, Netherlands; Isala, Netherlands; Ziekenhuis Sint Jansdal, Netherlands; Erasmus Universiteit Rotterdam, Netherlands; Bravis ziekenhuis Locatie Roosendaal, Netherlands; Franciscus Gasthuis en Vlietland, Netherlands; Universiteit Maastricht, Netherlands.

T1 colorectal cancers (T1CRC) are increasingly being treated by endoscopic submucosal dissection (ESD). After ESD of a T1CRC, completion surgery is indicated in a subgroup of patients. Currently, the influence of ESD on surgical morbidity and mortality is unknown. The aim of this study was to compare 90-day morbidity and mortality of completion surgery after ESD to primary surgery. The completion surgery group consisted of suspected T1CRC patients from a multicenter prospective ESD database (2014–2020). The primary surgery group consisted of pT1CRC patients from a nationwide surgical registry (2017–2019). Patients with rectal or sigmoidal cancers were selected. Patients receiving neoadjuvant therapy were excluded. Propensity score adjustment was used to correct for confounders. In total, 411 patients were included: 54 in the completion surgery group (39 pT1, 15 pT2) and 357 in the primary surgery group with pT1CRC. Adverse event rate was 24.1% after completion surgery and 21.3% after primary surgery. After completion surgery 90-day mortality did not occur, though one patient died in the primary surgery group. After propensity score adjustment, lymph node yield did not differ significantly between the groups. Among other morbidity-related outcomes, stoma rate (OR 1.298 95%-CI 0.587-2.872, p = 0.519) and adverse event rate (OR 1.162; 95%-CI 0.570-2.370, p = 0.679) also did not differ significantly. A subgroup analysis was performed in patients undergoing rectal surgery. In this subgroup (37 completion and 136 primary surgery), these morbidity outcomes also did not differ significantly. In conclusion, this study suggests that ESD does not compromise morbidity or 90-day mortality of completion surgery.

Background and study aims Overcoming logistical obstacles for the implementation of colorectal endoscopic submucosal dissection (ESD) requires accurate prediction of procedure times. We aimed to evaluate existing and new prediction models for ESD duration. Patients and methods Records of all consecutive patients who underwent single, non-hybrid colorectal ESDs before 2020 at three Dutch centers were reviewed. The performance of an Eastern prediction model [GIE 2021;94(1):133-144] was assessed in the Dutch cohort. A prediction model for procedure duration was built using multivariable linear regression. The model's performance was validated using internal validation by bootstrap resampling, internal-external cross-validation and external validation in an independent Swedish ESD cohort. Results A total of 435 colorectal ESDs were analyzed (92% en bloc resections, mean duration 139 minutes, mean tumor size 39 mm). The performance of current unstandardized time scheduling practice was suboptimal (explained variance: R 2 =27%). We successfully validated the Eastern prediction model for colorectal ESD duration <60 minutes (c-statistic 0.70, 95% CI 0.62-0.77), but this model was limited due to dichotomization of the outcome and a relatively low frequency (14%) of ESDs completed <60 minutes in the Dutch centers. The model was more useful with a dichotomization cut-off of 120 minutes (c-statistic: 0.75; 88% and 17% of "easy" and "very difficult" ESDs completed <120 minutes, respectively). To predict ESD duration as continuous outcome, we developed and validated the six-variable cESD-TIME formula ( https://cesdtimeformula.shinyapps.io/calculator/ ; optimism-corrected R 2 =61%; R 2 =66% after recalibration of the slope). Conclusions We provided two useful tools for predicting colorectal ESD duration at Western centers. Further improvements and validations are encouraged with potential local adaptation to optimize time planning.

Abstract Background The sole presence of deep submucosal invasion is shown to be associated with a limited risk of lymph node metastasis. This justifies a local excision of suspected deep submucosal invasive colon carcinomas (T1 CCs) as a first step treatment strategy. Recently Colonoscopy-Assisted Laparoscopic Wedge Resection (CAL-WR) has been shown to be able to resect pT1 CRCs with a high R0 resection rate, but the long term outcomes are lacking. The aim of this study is to evaluate the safety, effectiveness and long-term oncological outcomes of CAL-WR as primary treatment for patients with suspected superficial and also deeply-invasive T1 CCs. Methods In this prospective multicenter clinical trial, patients with a macroscopic and/or histologically suspected T1 CCs will receive CAL-WR as primary treatment in order to prevent unnecessary major surgery for low-risk T1 CCs. To make a CAL-WR technically feasible, the tumor may not include > 50% of the circumference and has to be localized at least 25 cm proximal from the anus. Also, there should be sufficient distance to the ileocecal valve to place a linear stapler. Before inclusion, all eligible patients will be assessed by an expert panel to confirm suspicion of T1 CC, estimate invasion depth and subsequent advise which local resection techniques are possible for removal of the lesion. The primary outcome of this study is the proportion of patients with pT1 CC that is curatively treated with CAL-WR only and in whom thus organ-preservation could be achieved. Secondary outcomes are 1) CAL-WR’s technical success and R0 resection rate for T1 CC, 2) procedure-related morbidity and mortality, 3) 5-year overall and disease free survival, 4) 3-year metastasis free survival, 5) procedure-related costs and 6) impact on quality of life. A sample size of 143 patients was calculated. Discussion CAL-WR is a full-thickness local resection technique that could also be effective in removing pT1 colon cancer. With the lack of current endoscopic local resection techniques for > 15 mm pT1 CCs with deep submucosal invasion, CAL-WR could fill the gap between endoscopy and major oncologic surgery. The present study is the first to provide insight in the long-term oncological outcomes of CAL-WR. Trial registration CCMO register (ToetsingOnline), NL81497.075.22, protocol version 2.3 (October 2022).

Background and study aims A free resection margin (FRM) > 1 mm after local excision of a T1 colorectal cancer (CRC) is known to be associated with a low risk of local intramural residual cancer (LIRC). The risk is unclear, however, for FRMs between 0.1 to 1 mm. This study evaluated the risk of LIRC after local excision of T1 CRC with FRMs between 0.1 and 1 mm in the absence of lymphovascular invasion (LVI), poor differentiation and high-grade tumor budding (Bd2–3). Patients and methods Data from all consecutive patients with local excision of T1 CRC between 2014 and 2017 were collected from 11 hospitals. Patients with a FRM ≥ 0.1 mm without LVI and poor differentiation were included. The main outcome was risk of LIRC (composite of residual cancer in the local excision scar in adjuvant resection specimens or local recurrence during follow-up). Tumor budding was also assessed for cases with a FRM between 0.1 and 1mm. Results A total of 171 patients with a FRM between 0.1 and 1 mm and 351 patients with a FRM > 1 mm were included. LIRC occurred in five patients (2.9 %; 95 % confidence interval [CI] 1.0–6.7 %) and two patients (0.6 %; 95 % CI 0.1–2.1 %), respectively. Assessment of tumor budding showed Bd2–3 in 80 % of cases with LIRC and in 16 % of control cases. Accordingly, in patients with a FRM between 0.1 and 1 mm without Bd2–3, LIRC was detected in one patient (0.8%; 95 % CI 0.1–4.4 %). Conclusions In this study, risks of LIRC were comparable for FRMs between 0.1 and 1 mm and > 1 mm in the absence of other histological risk factors.