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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06736301

Enrollment

Registered

2024-12-16

Start date

2024-12-15

Completion date

2027-11-30

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Duodenal Stricture

Keywords

duodenal stricture, fully covered stent

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.

Interventions

DEVICEa fully covered stent

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactChangqing Sun

18851675250@163.com18851675250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026