Prospective single-center feasible study of innovative autorelease bile duct supporter to delay adverse events after endoscopic papillectomy

BACKGROUND: Conventional endoscopic papillectomy (EP) is safe and effective for the treatment of small papilla adenoma to even large laterally spreading tumors of duodenum lesions. As reported by some existing studies, temporarily placing a prophylactic stent in the pancreatic and bile duct can lower the risk of this perioperative complication. AIM: To evaluate the usefulness, convenience, safety, and short-term results of a novel autorelease bile duct supporter after EP procedure, especially the effectiveness in preventing EP. METHODS: A single-center comparison study was conducted to verify the feasibility of the novel method. After EP, a metallic endoclip and human fibrin sealant kit were applied for protection. The autorelease bile duct supporter fell into the duct segment and the intestinal segment. Specifically, the intestinal segment was extended by nearly 5 cm as a bent coil. The bile was isolated from the pancreatic juice using an autorelease bile duct supporter, which protected the wound surface. The autorelease bile duct supporter fell off naturally and arrived in colon nearly 10 d after the operation. RESULTS: En bloc endoscopic resection was performed in 6/8 patients (75%), and piecemeal resection was performed in 2/8 of patients (25%). None of the above patients were positive for neoplastic lymph nodes or distant metastasis. No cases of mortality, hemorrhage, delayed perforation, pancreatitis, cholangitis or duct stenosis with the conventional medical treatment were reported. The autorelease bile duct supporter in 7 of 8 patients fell off naturally and arrived in colon 10 d after the operation. One autorelease bile duct supporter was successfully removed using forceps or snare under endoscopy. No recurrence was identified during the 8-mo (ranging from 6-9 mo) follow-up period. CONCLUSION: In brief, it was found that the autorelease bile duct supporter could decrease the frequency of procedure-associated complications without second endoscopic retraction. Secure closure of the resection wound with clips and fibrin glue were indicated to be promising and important for the use of autorelease bile duct supporters. Well-designed larger-scale comparative studies are required to confirm the findings of this study.