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

NCT06736301 | Recruiting

• 1 other identifier: DZQH-KYLL-24-40
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Duodenal Stricture

Keywords

duodenal stricture; fully covered stent

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate 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.

  at 30 days post-operation

Study Arms (1)

stent

EXPERIMENTAL

a double pig-tail stent for cross fixation of a fully covered stent

Device: a fully covered stent

Interventions

a fully covered stent DEVICE

a double pig-tail stent for cross fixation of a fully covered stent

stent

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shupei Li: lead

Study Sites (1)

Fully Covered Metal Stents

Nanjing, Jiangsu, 210000, China

RECRUITING

Central Study Contacts

Changqing Sun

CONTACT

18851675250; 18851675250@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)