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Recruiting NCT06736301

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

No phase Interventional Benign Duodenal Stricture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a fully covered stent.
Who it may be relevant to
Registry conditions: Benign Duodenal Stricture. Basic parameters: up to 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Clinical remission rate at 30 days post-operation [Time frame: at 30 days post-operation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fully Covered Metal Stents — Nanjing

Identifiers

NCT: NCT06736301 · DZQH-KYLL-24-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗