Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma

NCT ID: NCT06301048

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2023-12-07

Brief Summary

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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

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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.

Conditions

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Duodenal Adenoma Complication of Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pancreatic Stenting Group

performed pancreatic duct stent placement after endoscopic papillectomy

Stent Placement in Pancreatic and Bile Ducts

Intervention Type PROCEDURE

Post-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning.

Non-Pancreatic Stenting Group

have not performed pancreatic duct stent placement after endoscopic papillectomy

No interventions assigned to this group

Biliary Stenting Group

performed common bile duct stent placement after endoscopic papillectomy

Stent Placement in Pancreatic and Bile Ducts

Intervention Type PROCEDURE

Post-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning.

Non-Biliary Stenting Group

have not performed common bile duct stent placement after endoscopic papillectomy

No interventions assigned to this group

Interventions

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Stent Placement in Pancreatic and Bile Ducts

Post-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fujing Lv, M.D.

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BFHHZS20230203

Identifier Type: -

Identifier Source: org_study_id

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