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NCT Number: NCT06736301

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

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

Recruiting

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fully Covered Metal Stents

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Changqing Sun

CONTACT

[email protected]

18851675250

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a fully covered stent

Device

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

Primary outcomes

  1. Clinical remission rate at 30 days post-operation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Changqing Sun

CONTACT

[email protected]

18851675250

Sponsors and collaborators

Lead sponsor

Shupei Li

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.