Double Pig Tail Stent-assisted Fixation of Fully Covered Metal Stents for the Treatment of Benign Duodenal Strictures

Not Applicable

Recruiting

• Conditions: Benign Duodenal Stricture

• Registration Number: NCT06736301
• Lead Sponsor: Shupei Li

Brief Summary

Double Pig Tail Stent-assisted Fixation of Fully-Covered Metal Stents for the Treatment of Benign Duodenal Strictures

Detailed Description

This study uses a double pig-tail stent for cross fixation of a fully-covered stent in the duodenum to reduce the incidence of displacement and ensure the stent can effectively expand the narrowed area, thereby alleviating patient symptoms.

The aim of this study is to explore the safety and efficacy of a double pig-tail stent-assisted fixation of a fully-covered stent for the treatment of benign duodenal strictures, further clarifying its long-term efficacy and providing strong support for the placement of fully-covered stents in treating benign duodenal strictures.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-12
• Study Start: 2024-12-15
• Study First Posted: 2024-12-16
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. The subjects voluntarily signed the informed consent form for this trial;
2. Patients diagnosed with benign duodenal stricture;
3. Symptoms of upper gastrointestinal obstruction, such as nausea, vomiting, abdominal pain, or changes in bowel habits, occurring before admission or during hospitalization;
4. Patients with refractory strictures who have failed multiple balloon dilations;
5. Age < 75 years.

Exclusion Criteria

1. Gastrointestinal perforation;
2. Distal small bowel obstruction or multiple segments of small bowel obstruction;
3. Coagulation disorders;
4. Strictures or obstructions caused by malignant tumors;
5. Severe comorbidities involving the heart, brain, lungs, kidneys, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical remission rate at 30 days post-operation	at 30 days post-operation	Clinical remission: Symptoms of duodenal obstruction are relieved, and the postoperative GOOSS score improves by at least one grade compared to preoperative values.

Trial Locations

Locations (1)

Fully Covered Metal Stents; 🇨🇳 Nanjing, Jiangsu, China