Utility of Transpapillary Biopsy and Endoscopic Ultrasound-Guided Tissue Acquisition for Comprehensive Genome Profiling of Unresectable Biliary Tract Cancer.

Tissue sampling in biliary tract cancer (BTC) is generally performed through transpapillary biopsy (TPB) or endoscopic ultrasound-guided tissue acquisition (EUS-TA). For the first time, we compared the suitability of specimens obtained using TPB and EUS-TA to determine the optimal tissue-sampling method for comprehensive genome profiling (CGP) analysis in patients with unresectable BTC (UR-BTC). Pathology precheck criteria for CGP analysis comprised the OncoGuide NCC Oncopanel System (NCCOP) and FoundationOne CDx (F1CDx). Seventy-eight patients with UR-BTC (35 TPB and 43 EUS-TA) were included. The NCCOP analysis suitability achievement rate was higher in EUS-TA specimens than in TPB specimens (34.9% vs. 8.6%, p = 0.007), whereas that of F1CDx was 0% in both groups. EUS-TA was identified as an independent factor that contributed to the suitability of the NCCOP analysis. The suitability of the NCCOP analysis of EUS-TA specimens showed a tendency to be higher for mass lesions (43.8% vs. 9.1%, p = 0.065), especially for target size ≥ 18.5 mm, and lower for perihilar cholangiocarcinoma (0% vs. 41.7%, p = 0.077). In TPB, papillary-type lesions (66.7% vs. 3.2%, p = 0.016) and peroral cholangioscopy-assisted biopsies (50.0% vs. 3.3%, p = 0.029) showed better potential for successful NCCOP analysis. EUS-TA is suitable for NCCOP analysis in UR-BTC and may be partially complemented by TPB.

Study Protocol for a Prospective Self-Controlled Trial on Success in Meeting Comprehensive Genomic Profiling Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-Guided Tissue Acquisition Using a 19G Needle from Primary and Metastatic Lesions in Pancreatic Cancer with Metastatic Lesions: The PRIMATE Study.

EUS-TA in unresectable pancreatic cancer requires not only a tissue diagnosis but also tissue collection in anticipation of comprehensive genomic profiling. However, the optimal puncture target remains controversial. Therefore, the Primary and Metastatic Lesions in Pancreatic Cancer (PRIMATE) study was designed to clarify the optimal target by comparing the success rates for meeting OncoGuide NCC Oncopanel (NOP) analysis criteria on pre-check primary and metastatic lesion specimens obtained during the same EUS-TA session in patients with invasive pancreatic ductal adenocarcinoma. In this ongoing prospective study, two specimens, each from primary and metastatic lesions, are obtained by EUS-TA (typically using a 19G fine-needle biopsy needle) in patients with invasive pancreatic ductal adenocarcinoma. The primary endpoint is the proportion of EUS-TA specimens that meet NOP analysis criteria during pre-check (i.e., tumor cellularity of ≥20% and a tissue area of ≥4 mm2), which are then compared between primary and metastatic lesions. This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2022-168). The results of this study will be reported at an international conference and published in an international peer-reviewed journal. The trial registration number is UMIN 000048966.

Comparison of stent patency between EUS-guided hepaticogastrostomy with bridging and endoscopic transpapillary biliary drainage for hilar obstruction.

Background and study aims Endoscopic ultrasound-guided hepaticogastrostomy with bridging between the left and right bile ducts is an alternative to endoscopic transpapillary drainage for malignant hilar biliary obstruction. We aimed to analyze the long-term stent patency of endoscopic ultrasound-guided hepaticogastrostomy with bridging. Patients and methods Patients who underwent endoscopic ultrasound-guided hepaticogastrostomy with bridging between April 2018 and July 2023 were retrospectively analyzed. We retrospectively compared the stent patency of these patients with that of the individuals who underwent endoscopic transpapillary drainage-multi-stenting using unmatched (entire) and propensity score-matched cohorts. Results Endoscopic ultrasound-guided hepaticogastrostomy with bridging had a technical success rate of 90% (18/20). Adverse events were minimal. The number of clinical success cases was 17 and 82 for endoscopic ultrasound-guided hepaticogastrostomy with bridging using metallic stent and endoscopic transpapillary drainage-multi-stenting, respectively. The recurrent biliary obstruction rate was 17.6% and 58.5% for endoscopic ultrasound-guided hepaticogastrostomy with bridging and endoscopic transpapillary drainage-multi-stenting, respectively; the median time to recurrent biliary obstruction (days) was significantly longer for endoscopic ultrasound-guided hepaticogastrostomy with bridging in the entire (not reached vs. 104, P =0.03) and propensity score-matched (183 vs. 79, P =0.05) cohorts. The non-recurrent biliary obstruction rate for endoscopic ultrasound-guided hepaticogastrostomy with bridging was 91.6% at 3 and 6 months and 57% at 12 months. Multivariate analyses revealed that endoscopic ultrasound-guided hepaticogastrostomy with bridging contributed to a lower recurrent biliary obstruction incidence (hazard ratio, 0.31, P =0.05) without significant difference. Conclusions Stent patency was significantly better for endoscopic ultrasound-guided hepaticogastrostomy with bridging. However, future prospective studies are needed.

Feasibility and safety of a novel plastic stent designed specifically for endoscopic ultrasound-guided pancreatic duct drainage.

Background and study aims Endoscopic ultrasound-guided pancreatic duct drainage (EUS-PD) is emerging as an effective alternative treatment for obstructive pancreatitis after unsuccessful endoscopic retrograde pancreatography (ERP). However, the high incidence of adverse events associated with EUS-PD (approximately 20%) remains an issue. Recently, we developed a novel plastic stent for EUS-PD, with a radiopaque marker positioned at approximately one-third of the length from the distal end of the stent and side holes positioned exclusively distal to the marker. This study aimed to evaluate the feasibility and safety of using this stent in EUS-PD. Patients and methods We retrospectively reviewed data from 10 patients who underwent EUS-PD with the novel plastic stent at the National Cancer Center Hospital between March 2021 and October 2023. Technical and clinical success, procedure times, adverse events (AEs), recurrent pancreatic duct obstruction (RPO), and time to RPO were assessed. Results Of the 10 patients, five had postoperative benign pancreaticojejunal anastomotic strictures and five had malignant pancreatic duct obstruction. The technical and clinical success rates were both 100% (10/10). An AE (self-limited abdominal pain) occurred in one patient (10.0%). Two patients (20.0%) died of their primary disease during the follow-up period (median, 44 days; range, 25-272 days). The incidence of RPO was 10.0% (1/10), and the 3-month non-RPO rate was 83.3%. Conclusions The novel plastic stent shows potential as a useful and safe tool in EUS-PD.

Study protocol for a prospective, multicentre, phase II trial on endoscopic treatment using two fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy.

INTRODUCTION: The current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown a high rate of stenosis recurrence, which indicates an insufficient response to treatment. Three prospective studies on fully covered self-expandable metallic stent (FC-SEMS) treatment for benign HJAS used the stenosis resolution rate as the primary endpoint, and no study has yet used the long-term non-stenosis rate (at 12 months) as the primary endpoint. METHODS AND ANALYSIS: We launched the 'saddle-cross study', which will be conducted as a multicentre, prospective intervention of endoscopic treatment using two modified FC-SEMSs (BONASTENT️ M-Intraductal) that have been improved for benign stenosis in patients with benign HJAS, with the long-term non-restenosis rate (at 12 months) as the primary endpoint. This study aims to evaluate the long-term non-restenosis rate (at 12 months) and safety of the saddle-cross technique for benign HJAS. We plan to enrol 50 participants. ETHICS AND DISSEMINATION: This study has been approved by the Certified Review Board of the National Cancer Center, Japan (CRB3180009). The results will be reported at various conferences and published in international peer-reviewed journals.

Endoscopic Treatment for Submucosal Heterotopic Gastric Gland in a Case Observed over Nine Years from Development to Enlargement.

A 70-year-old Japanese man with a submucosal gastric mass that continued to increase in size underwent endoscopic submucosal dissection using the pocket creation method. Histologically, some epithelial cell nuclei were enlarged, but there was little atypia overall and no sign of malignancy, suggesting a diagnosis of submucosal heterotopic gastric gland (SHGG). SHGG that enlarges over time has been associated with gastric cancer, but a preoperative diagnosis is difficult. This case was very valuable, as it enabled us to follow the course of SHGG over a period of about nine years, from the onset to enlargement.

Usefulness of duckbill-type anti-reflux self-expandable metal stents for distal malignant biliary obstruction with duodenal invasion: A pilot study.

Objectives: Early obstruction of a self-expandable metal stent placed for distal malignant biliary obstruction is more likely to occur in the presence of duodenal invasion. An anti-reflux self-expandable metal stent (ARMS) has been developed for the purpose of preventing duodenal fluid reflux into the bile duct. In this study, we evaluated the usefulness and safety of a duckbill-type ARMS (D-ARMS) in the situation of duodenal invasion. Methods: We retrospectively analyzed 10 consecutive patients who received D-ARMS for distal malignant biliary obstruction with duodenal invasion. We evaluated non-occlusion cholangitis, recurrent biliary obstruction (RBO), and adverse events after D-ARMS placement. Results: There were no cases of non-occlusion cholangitis. RBO was observed in 2 patients (20%), and time to RBO was 236 days and 117 days, respectively. The causes of RBO were overgrowth and sludge formation. The median time to RBO was 382 days (range, 117-382 days). Only one adverse event was observed (cholecystitis). Conclusions: D-ARMS shows potential as an optimal ARMS.