Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma

Completed

• Conditions: Duodenal Adenoma; Complication of Treatment
• Interventions: Procedure: Stent Placement in Pancreatic and Bile Ducts

• Registration Number: NCT06301048
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.

Detailed Description

Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. In a retrospective analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. Complete resection rates did not significantly differ between patients with or without stent placement. Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group. Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up. Thus, Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma.

Study Timeline

• Study Start: 2023-11-07
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Status Verified: 2024-01
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Age ≥18 years.
• Identification of duodenal papillary lesions via gastroscopy or duodenoscopy.
• Intraductal involvement <20mm.
• Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging).
• Postoperative biopsy confirming adenoma.

Exclusion Criteria

• Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome.
• Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic Stenting Group	Stent Placement in Pancreatic and Bile Ducts	performed pancreatic duct stent placement after endoscopic papillectomy
Biliary Stenting Group	Stent Placement in Pancreatic and Bile Ducts	performed common bile duct stent placement after endoscopic papillectomy

Primary Outcome Measures

Name	Time	Method
Rate of complete resection	1 week after the operation	The pathological margins results were used to determine whether the lesion was completely resected.
Rate of complications	through study completion, an average of 1 year	Complications related with Endoscopic Papillectomy (EP), including pancreatitis, cholangitis, bleeding, perforation, hyperamylasemia, stenosis. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination during follow-up were measured.

Secondary Outcome Measures

Name	Time	Method
Rate of recurrence	Within 3 years after the operation	Endoscopic observation and biopsy results were used to find recurrence.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China