Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors

NCT07446543 | Not Yet Recruiting DMC

• 1 other identifier: NYSZYYEC2025K110R002
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.

Conditions

Ampulla of Vater Neoplasms; Ampullary Adenoma; Ampullary Carcinoma

Keywords

endoscopic papillectomy; ampullary tumor; negative-pressure drainage; pancreatic duct stent; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Incidence of post-endoscopic papillectomy pancreatitis

  Diagnosis will be based on the revised Atlanta classification, incorporating clinical symptoms (abdominal pain), laboratory findings (serum amylase or lipase ≥3 times the upper limit of normal), and imaging evidence (CT or MRI indicating pancreatitis). Daily assessment and documentation will be performed by study physicians.

  Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)

Secondary Outcomes (8)

• R0 resection rate (complete resection)

  At final pathology assessment (upon pathology report issuance; typically within 7 days after endoscopic papillectomy）

• Technical success rate of intended drainage placement

  During the endoscopic papillectomy procedure (Day 0), assessed immediately after attempted completion of the assigned drainage method

• Incidence of hyperamylasemia

  6 hours, 24 hours, and 48 hours after endoscopic papillectomy.

• Length of hospital stay

  From admission to hospital discharge (up to 7 days)

• En bloc resection rate

  Immediately after lesion resection during the endoscopic papillectomy procedure (Day 0)

Study Arms (2)

Negative Pressure Drainage Group

EXPERIMENTAL

Participants undergo endoscopic papillectomy followed by intraoperative placement of a nasally inserted negative-pressure drainage tube positioned distal to the papilla in the descending duodenum. Continuous negative suction is applied to facilitate pancreatic and duodenal drainage.

Device: Placement of a negative pressure drainage tube

Pancreatic Duct Stenting Group

ACTIVE COMPARATOR

Participants undergo endoscopic papillectomy followed by prophylactic placement of a plastic pancreatic duct stent under endoscopic and fluoroscopic guidance to promote pancreatic drainage and reduce the risk of postoperative pancreatitis.

Procedure: Placement of a pancreatic duct stent

Interventions

Placement of a negative pressure drainage tube DEVICE

A flexible polymer drainage tube is inserted transnasally immediately after endoscopic papillectomy and advanced so that the tip rests distal to the papilla in the descending duodenum. The external end is connected to a manual suction device to provide continuous negative pressure and promote evacuation of pancreatic secretions and duodenal contents. The tube is monitored for function, displacement, and blockage and is removed approximately 72 hours postprocedure if no significant complications occur. Rescue therapy: in the event of significant intraoperative bleeding, perforation, or other device-related complications, a pancreatic duct stent may be placed while maintaining the negative-pressure tube for continued drainage.

Negative Pressure Drainage Group

Placement of a pancreatic duct stent PROCEDURE

A plastic pancreatic duct stent is placed under endoscopic and fluoroscopic guidance immediately after endoscopic papillectomy to facilitate pancreatic drainage and reduce the risk of postoperative pancreatitis. Stent diameter and length are selected by the endoscopist based on intraoperative findings and preoperative imaging. If stent placement fails after three or more attempts or cumulative placement time exceeds 15 minutes, the procedure is considered unsuccessful and a nasally inserted negative-pressure drainage tube will be used as rescue therapy. Successfully placed stents are scheduled for endoscopic removal within 30 days.

Pancreatic Duct Stenting Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
• Scheduled to undergo endoscopic papillectomy

You may not qualify if:

• Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
• Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
• Lesion diameter \>40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
• Known familial adenomatous polyposis (FAP).
• Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
• Coagulopathy or bleeding disorders.
• Pregnancy or lactation.

Sponsors & Collaborators

• Cui Xiaobing: lead

Central Study Contacts

xiaobing cui

CONTACT

+8613631312723; xbing119@163.com

kaiyun liu

CONTACT

liu12345666@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Participants will be randomized 1:1 to one of two parallel groups: negative-pressure drainage or pancreatic duct stenting. All participants will undergo standardized endoscopic papillectomy (EP) performed by experienced endoscopists. In the experimental arm, a nasally inserted negative-pressure drainage tube will be positioned distal to the papilla in the descending duodenum and connected to a manual suction device to provide continuous drainage; in the comparator arm, a prophylactic pancreatic duct stent will be placed after EP. The trial will compare the two groups with respect to the primary outcome (incidence of post-EP pancreatitis) and secondary outcomes (other procedure-related complications, procedure and device-placement time, technical success rate, resection quality including en-bloc and R0 rates, length of hospital stay and total hospitalization cost, and postoperative hyperamylasemia). This is an open-label study; imaging review and statistical analysis will be performed b

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: March 3, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share