BACKGROUND:Large oral protrusions may increase the difficulty of biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP) and often require precut sphincterotomy. Precut sphincterotomy is a risk factor for post-ERCP pancreatitis (PEP). However, this may be reduced by a primary precut sphincterotomy. This study aimed to evaluate the results of biliary cannulation after primary precut sphincterotomy in patients with large oral protrusions identified during ERCP. METHODS:In this prospective observation study, we included 38 patients with naïve papillae who underwent ERCPs between January 2021 and December 2022 that revealed large oral protrusions and who underwent primary precut sphincterotomies as the biliary cannulation method. Primary precut sphincterotomy was performed by an experienced endoscopist in all cases. RESULTS:The biliary cannulation success rate for primary precut sphincterotomies was 100% (38/38 patients). There were seven cases (18.4%) of ERCP-related adverse events, specifically bleeding. Of these, six (15.8%) were mild and one (2.6%) was moderate. No cases of PEP were observed. CONCLUSIONS:Primary precut sphincterotomy for large oral protrusions performed by an experienced endoscopist had a high biliary cannulation success rate without the occurrence of PEP. This procedure can be used for biliary cannulation in patients with large oral protrusions (University Hospital Medical Information Network-Clinical Trials Registry number: UMIN000042805).

Objectives:Balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (BE-assisted ERCP) is performed for hepaticojejunostomy anastomotic stricture (HJAS) after biliary-enteric anastomosis. Although endoscopic balloon dilation (EBD) and plastic stent (PS) placement are commonly performed, they result in high recurrence rates. Studies have demonstrated the efficacy of fully covered self-expanding metal stents (FCSEMS) in HJAS management; however, none have systematically evaluated the outcomes of 6-month placement. Therefore, this retrospective study aimed to evaluate the efficacy and safety of a 6-month FCSEMS placement for benign refractory or recurrent HJAS. Methods:We evaluated patients who underwent initial treatment with EBD alone or EBD plus PS placement via BE-assisted ERCP between April 2015 and March 2024. Among them, patients with refractory or recurrent HJAS received 6-month FCSEMS placements. The study outcomes were HJAS resolution, adverse events (AEs), and recurrence rates. Results:Among 92 patients who underwent initial EBD alone or EBD with PS placement, the HJAS resolution rate was 90.2%. The median follow-up period after the initial treatment was 16.1 months, with recurrence observed in 48.2% of patients. Among the 34 patients with refractory or recurrent HJAS, FCSEMS placement achieved a resolution rate of 97.1% in a median of 182 days. AEs occurred in 14.7% of patients (moderate, n = 3; mild, n = 2) following FCSEMS placement. During a median follow-up of 30.9 months, no recurrence was observed after HJAS resolution using FCSEMS. Conclusions:The 6-month FCSEMS placement for refractory or recurrent HJAS showed high efficacy and safety, indicating its potential as a preferred treatment option.

Recent guidelines on biliary cannulation are lacking. This guideline is an initiative of the World Endoscopy Organization (WEO) with the involvement of a panel of experts from Asia, Europe, and America. Relevant clinical questions on four areas (post-endoscopic retrograde cholangiopancreatography [ERCP] pancreatitis [PEP] prophylaxis, biliary cannulation techniques, sphincterotomy/papillary balloon dilation, and biliary cannulation in special circumstances) were developed and answered after systematic reviews of the literature and using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Successful biliary cannulation and sphincterotomy are cornerstones of ERCP and are indispensable for almost all therapeutic and advanced diagnostic procedures. However, adverse events, particularly PEP, may commonly occur and impair patients' outcomes. A high cannulation rate and a low rate of PEP are quality indicators for ERCP and should be the goal of all endoscopists. With this guideline we aimed to provide clinical practice advice applicable worldwide, regardless of resources and expertise availability. The main recommendations focus on specific aspects of ERCP, including pre-, intra-, and postprocedural measures to reduce the risk of PEP, the technique for an initial biliary cannulation attempt, options for cannulation in cases of difficult biliary access, alternatives to ERCP in case of failure (percutaneous- and endoscopic ultrasound-guided), and biliary access in altered anatomy (periampullary diverticulum and postsurgical anatomy) and in the presence of duodenal stenosis.

ABSTRACTBackground and AimManaging benign biliary stricture endoscopically is complicated and challenging. This study aimed to evaluate the safety and efficacy of a 6‐month placement of a fully covered self‐expanding metallic stent for refractory benign biliary stricture.MethodsTwenty‐two patients with refractory benign biliary stricture (13 with chronic pancreatitis and 9 without) were recruited from five higher tertiary care centers. All patients received a planned 6‐month fully covered self‐expanding metallic stent placement. Primary outcomes included clinical success, technical success of stent removal, adverse events, and stricture recurrence.ResultsOf the 21 cases (one case was excluded owing to malignant findings), fully covered self‐expanding metallic stent placement was successful in all cases, with contralateral bile duct plastic stents used in three patients and stents remaining in place for 6 months in 16 of 21 patients. Distal stent migration occurred in three cases, two of which had resolved strictures. Adverse events were observed in 19.0% of patients: one case of severe cholangitis, two cases of mild cholangitis, and one case of hyperplasia formation. No stent‐induced pancreatitis or cholecystitis occurred. All stents were removed successfully, and the treatment success rate was 85%. One patient experienced recurrent stricture 6.5 months post‐stent removal.ConclusionsA six‐month placement of a modified fully covered self‐expanding metallic stent effectively improved strictures and minimized stent‐induced Adverse events in patients with refractory benign biliary stricture.Trial RegistrationUMIN ID: UMIN000025027

Objectives Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is an increasingly used alternative treatment for malignant biliary obstructions. However, improvements to this approach are warranted. Recently, the use of a 22G puncture needle and a 0.018-inch guidewire (GW), as well as the double-GW technique (DGT), have been introduced and adopted by our institution. We retrospectively evaluated the outcomes of EUS-HGS, combined with DGT, using a 22G needle. Patients and Methods This study included 34 of 54 patients who underwent EUS-HGS, which was performed using a 22G puncture needle combined with DGT at Kitasato University Medical Center Hospital from October 2021 to March 2024. We retrospectively examined patients' backgrounds, the technical success rate (defined as the successful insertion of a stent from the stomach into the intended bile duct), clinical success rate (defined as a decrease in total bilirubin levels to either the normal range or to at least 50% of the prior value within 2 weeks), procedure time (defined as the time from endoscope insertion to stent deployment), incidence of complications, and changes in the angle between the puncture axis and bile duct axis resulting from the use of DGT. Endpoints and Data Analysis The primary endpoint was the technical success rate of EUS-HGS using a 22G needle combined with a DGT. Secondary endpoints included the clinical success rate, procedure time, GW angle at the puncture site before and after DGT, and incidence of complications. Descriptive statistics were performed. Results The technical and clinical success rates were 100 and 97.1%, respectively. The average procedure time was 16 minutes. The angle between the puncture and bile duct axis was 145.6 degrees before the DGT, which only involved a 0.018-inch GW; the angle increased to 161.1 degrees after the DGT, bringing the puncture and bile duct axis closer to alignment. The incidence of complications was 2.9%. Conclusion EUS-HGS with a 22G needle in conjunction with the DGT has a high procedural success rate and low incidence of complications. These two components complement each other and contribute to the overall efficiency and effectiveness of the procedure, even in challenging situations.

BACKGROUND Endoscopic retrograde cholangiopancreatography is a challenging procedure involving bile duct cannulation. Despite the development of several cannulation devices, none have effectively facilitated the procedure. AIM To evaluate the efficacy of a recently developed catheter for bile duct cannulation. METHODS We retrospectively examined 342 patients who underwent initial cholangiopancreatography. We compared the success rate of bile duct cannulation and the incidence of complications between the groups using existing and novel catheters. RESULTS The overall success rates of bile duct cannulation were 98.3% and 99.1% in the existing and novel catheter groups, respectively (P = 0.47). The bile duct cannulation rate using the standard technique was 73.0% and 82.1% in the existing and novel catheter groups, respectively (P = 0.042). Furthermore, when catheterization was performed by expert physicians, the bile duct cannulation rate was significantly higher in the novel catheter group (81.3%) than in the existing catheter group (65.2%) (P = 0.017). The incidence of difficult cannulation was also significantly lower in the novel catheter group (17.4%) than in the existing catheter group (33.0%) (P = 0.019). CONCLUSION The novel catheter improved the bile duct cannulation rate using the standard technique and reduced the frequency of difficult cannulation cases, valuable tool in endoscopic retrograde cholangiopancreatography procedures performed by experts.

BACKGROUND:There are few reports on the usefulness of endoscopic ultrasound-guided tissue acquisition (EUS-TA) for upper gastrointestinal subepithelial lesions (SELs) < 20 mm with on-site stereomicroscopic assessment. AIM:This study is aimed at investigating the usefulness of EUS-TA combined with on-site stereomicroscopic assessment using fine-needle biopsy (FNB) for SELs < 20 mm. METHODS:Participants (n = 133) underwent EUS-TA combined with on-site stereomicroscopic assessment using a 22-gauge FNB needle for upper gastrointestinal SELs between January 2018 and January 2022. We conducted a comparative study of diagnostic results after dividing the participants into two groups on the basis of lesion size: < 20 and ≥ 20 mm. RESULTS:There were 42 cases in the < 20-mm group and 91 cases in the ≥ 20-mm group. The diagnostic yield of EUS-TA in all cases was 97.7%, with values of 97.6% in the < 20-mm group and 97.8% in the ≥ 20-mm group and no significant difference between the groups. A total of 298 passes were made. The tissue sampling rate was 99.0%, and specimens with stereomicroscopically visible white cores (SVWCs) ≥ 4 mm were sampled at a rate of 87.2%. There was no significant difference in the sampling rate of specimens with SVWCs ≥ 4 mm between the groups. The diagnostic sensitivity in specimens with SVWC ≥ 4 mm was 98.5% (256/260 passes). Multivariate analysis showed that this factor significantly contributed to diagnosis (odds ratio 24.396, 95% confidence interval: 1.6596-4.7292, p < 0.001). CONCLUSIONS:EUS-TA using a FNB needle combined with on-site stereomicroscopic assessment is a useful diagnostic method for < 20-mm SELs.

BACKGROUND:Endoscopic retrograde cholangiopancreatography involves selective bile duct cannulation, which is often challenging and associated with complications. In difficult cannulation cases, early precutting is frequently used. However, its efficacy and optimal indications require further evaluation. AIM:To evaluate the efficacy and safety of early precut (EP) in difficult bile duct cannulation. METHODS:This retrospective analysis of endoscopic retrograde cholangiopancreatography procedures was performed for bile duct cannulation in patients with naive papillae who required advanced cannulation techniques (ACTs). These patients were admitted between April 2020 and March 2024 and were analyzed for risk factors, success rates, and complications. Outcomes were compared between the EP group and the conventional other ACTs group, with a focus on cases with oral protrusion large (oral protrusion-L). RESULTS:The need for ACTs was identified as an independent risk factor for complications [odds ratio (OR) = 5.4; 95% confidence interval: 1.887-15.53]. Malignant biliary strictures (OR = 2.58) and oral protrusion-L (OR = 2.77) were also identified as independent risk factors for requiring ACTs. The EP group had a significantly higher second-line cannulation success rate (97.9% vs 73.2%, P = 0.001) and lower complication rate (8.3% vs 39.0%, P = 0.001) than the other ACTs group. Additionally, similar benefits were observed in the oral protrusion-L cases. CONCLUSION:This study provides compelling evidence that EP is a viable alternative and a superior strategy in cases requiring ACTs, particularly oral protrusion-L.

Objectives: Interventional endoscopic ultrasonography (I-EUS) exposes patients to high levels of radiation exposure. However, no research on the fluoroscopy time required for each step of I-EUS has been published. That was the aim of this study. Materials and Methods: We retrospectively included patients who underwent endoscopic ultrasonography-guided biliary drainage (EUS-BD) and pancreatic duct drainage (EUS-PDD) in our hospital from October 2022 to November 2024. The procedure was categorized into four steps: step 1, transmural puncturing; step 2, guidewire placement; step 3, tract creation; and step 4, stent placement. We measured the fluoroscopy time required for each step via the fluoroscopic videos. Statistical Analysis: Continuous variables were described using medians and the first to third quartiles (Q1-Q3). Results: The study included 36 participants (EUS-BD: 33, EUS-PDD: 3). The median [Q1-Q3] fluoroscopy times required for steps 1 to 4 were 120 [96-152], 175 [123-449], 194 [101-303], and 171 [90-208] seconds, respectively, for EUS-BD and 169 [119-195], 302 [234-529], 435 [430-477], and 233 [170-266] seconds, respectively, for EUS-PDD. Conclusions: In I-EUS, the fluoroscopy time required for step 3, tract creation, was the longest. The technique needs to be improved, new devices developed, and clear communication be established among the operating team to prevent unnecessary fluoroscopy.

BACKGROUND:In single balloon-enteroscopy-assisted endoscopic retrograde cholangiopancreatography (SBE-assisted ERCP) for patients with surgically altered anatomies, precut sphincterotomy is performed as an advanced cannulation technique for difficult biliary cannulation cases. This study evaluated the safety and efficacy of precut sphincterotomy. METHODS:The study included patients who underwent SBE-assisted ERCP on a naive papilla with surgically altered anatomies (excluding Billroth-I reconstruction) from April 2015 to December 2023. The success rate of biliary cannulation and the complication incidence were analyzed retrospectively. RESULTS:A total of 231 patients were included. Scope insertion to the duodenal papilla was possible in 204 cases (88.3%), and biliary cannulation was attempted in 198 cases (85.7%). Standard cannulation was successful in 132 cases (66.7%), while an additional 10 cases (5.1%) successfully cannulated using pancreatic guide wire-assisted biliary cannulation. An additional 28 cases (14.1%) were successfully cannulated using precut sphincterotomy. Therefore, the overall biliary cannulation success rate was 85.9% (170 of 198 cases). The success rate of precut sphincterotomy was 66.7% (28 of 42 cases). Intraoperative bleeding caused by precut sphincterotomy occurred in 11.9%, and other complications were present in 16.7% of cases. CONCLUSIONS:Precut sphincterotomy is a one of the valuable techniques in SBE-assisted ERCP for surgically altered anatomies.

OBJECTIVES:This consensus was developed by the Asian EUS Group (AEG), who aimed to formulate a set of practice guidelines addressing various aspects of endoscopic ultrasound-guided tissue acquisition (EUS-TA). METHODS:The AEG initiated the development of consensus statements and formed an expert panel comprising surgeons, gastroenterologists, and pathologists. Three online consensus meetings were conducted to consolidate the statements and votes. The statements were presented and discussed in the first two consensus meetings and revised according to comments. Final voting was conducted at a third consensus meeting. The Grading of Recommendations, Assessment, Development, and Evaluation system was adopted to define the strength of the recommendations and quality of evidence. RESULTS:A total of 20 clinical questions and statements regarding EUS-TA were formulated. The committee recommended that fine-needle biopsy (FNB) needles be preferred over conventional fine-needle aspiration (FNA) needles for EUS-TA of subepithelial lesions. For solid pancreatic masses, rapid on-site evaluation is not routinely recommended when FNB needles are used. For dedicated FNB needles, fork-tip and Franseen-tip needles have essentially equivalent performance. CONCLUSION:This consensus provides guidance for EUS-TA, thereby enhancing the quality of EUS-TA.

Needle tract seeding (NTS) is a rare complication of endoscopic ultrasound-guided tissue acquisition (EUS-TA). Herein, we report the case of an 83 year-old man who presented with a solid mass in the pancreatic tail, measuring 35 mm in diameter, with cystic degeneration. EUS-TA was performed using a 22-gauge biopsy needle, with a single puncture via the stomach; however, no definitive pathological diagnosis was achieved. Due to the strong suspicion of malignancy, surgery was performed at the patient’s request, and the postoperative pathological diagnosis was pancreatic adenosquamous carcinoma. One year after surgery, computed tomography revealed a string of bead-like nodules within the gastric wall. Esophagogastroduodenoscopy revealed three submucosal, tumor-like raised lesions aligned in a row on the upper posterior wall of the gastric body. EUS detected a solid mass with cystic degeneration. Histological findings from EUS-TA specimens were consistent with those from the pancreatic resection specimen, leading to a diagnosis of NTS. Although reports of NTS have been increasing in recent years, cases of NTS occurring after only a single puncture remain extremely rare. This case clearly demonstrates that NTS can occur even after a single puncture, highlighting the importance of obtaining thorough informed consent regarding this risk prior to performing EUS-TA.

BACKGROUND AND AIM:No prospective studies have verified the incidence of cholecystitis in patients using the covered self-expandable metallic stent. In this study, we aimed to investigate the incidence of cholecystitis and its risk factors after low axial force covered self-expandable metallic stent placement for malignant distal biliary obstruction. METHODS:This multicenter prospective study included patients diagnosed with unresectable distal biliary obstruction between November 2019 and October 2022 who underwent low axial force covered self-expandable metallic stent placement. RESULTS:The technical success in the 93 analyzed patients was 100% and clinical success was 98.9%. The 70-mm covered self-expandable metallic stent was the most used in 53 patients (57.0%), followed by the 80-mm type in 27 patients (29.0%), 60-mm type in 12 patients (12.9%), and 50-mm type in 1 patient (1.1%). Cholecystitis after covered self-expandable metallic stent placement occurred in six patients (6.5%). The median time to onset was 46 days (range, 16-315 days), with 1 case in the early stage and five cases in the late stage. There was one mild case, one moderate case, and four severe cases. The presence of tumor involvement at the orifice of the cystic duct was identified as an independent risk factor (odds ratio, 17.0; 95% confidence interval, 1.5-195.1; p = 0.023). CONCLUSIONS:The presence of tumor involvement at the orifice of the cystic duct was an independent risk factor for the development of cholecystitis after low axial covered self-expandable metallic stent placement. TRIAL REGISTRATION:University Hospital Medical Information Network (UMIN) (http://www.umin.ac.jp, registration number: UMIN 000038209).

Background The cutoff value for stereomicroscopic on-site evaluation (SOSE) in endoscopic ultrasound-guided tissue acquisition (EUS-TA) has high diagnostic sensitivity when a Franseen needle is employed for upper gastrointestinal subepithelial lesions (SELs) (stereomicroscopically visible white core [SVWC] ≥ 4 mm). Aim We aimed to determine whether high diagnostic sensitivity could be obtained when EUS-TA was performed using a Fork-tip needle. Methods Twenty-one patients were prospectively registered. Patients underwent EUS-TA using a Fork-tip needle for upper gastrointestinal SELs at Kitasato University Hospital between January and November 2022. Punctures were made twice using the needle, and SOSE was conducted for each specimen. Blood and physical examination were performed to assess adverse events. Pathological diagnosis was made using hematoxylin and eosin-stained sections and immunohistochemical staining. Statistical comparisons were completed using Fisher’s exact tests. Results The diagnostic rate of EUS-TA was 100% (21/21 cases). The final diagnosis was gastrointestinal stromal tumor in 17 (81.0%) and leiomyoma in 4 (19.0%) patients. SOSE was conducted on all 42 punctures, and the tissue sampling rate was 100% (42/42 punctures). Specimens with SVWC ≥ 4 mm were collected in 97.6% punctures (41/42 punctures) and the diagnostic sensitivity for these specimens was 100% (41/41 punctures), which is significantly higher (p < 0.0238) compared to the absence of cutoff value (diagnostic sensitivity of 0%). No EUS-TA-related adverse events occurred. Conclusions EUS-TA combined with SOSE for upper gastrointestinal SEL using a fork-tip needle had a high diagnostic rate, and the cutoff value of SVWC ≥ 4 mm had high diagnostic sensitivity.

Background/Aims: To validate endoscopic ultrasound-guided tissue acquisition (EUS-TA) used in conjunction with stereomicroscopic on-site evaluation (SOSE) as a preoperative diagnostic tool for resectable pancreatic cancer (R -PC) and borderline resectable PC (BR -PC). Methods: Seventy-eight consecutive patients who underwent EUS-TA for suspected R -PC or BR -PC were enrolled. The primary endpoint was the sensitivity of EUS-TA together with SOSE based on the stereomicroscopically visible white core (SVWC) cutoff value. One or two sites were punctured by using a 22-gauge biopsy needle for EUS-TA, based on the SOSE findings. Results: We collected 99 specimens from 56 and 22 patients with R -PC and BR -PC, respectively. Based on the SOSE results, we performed 57 procedures with one puncture. The SVWC cutoff values were met in 73.7% and 73.1% of all specimens and in those obtained during the first puncture, respectively. The final diagnoses were malignant and benign tumors in 76 and two patients, respectively. The overall sensitivity, specificity, and accuracy of EUS-TA for the 78 lesions were 90.8%, 100%, and 91.0%, respectively. The sensitivity for malignant diagnosis based on the SVWC cutoff value were 89.5% and 90.4% for the first puncture and all specimens, respectively. Conclusions: The sensitivity of EUS-TA in conjunction with SOSE for malignancy diagnosis in patients with suspected R -PC or BRPC was 90.4%.