Using a special stent to treat 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

This study is testing a special stent to see if it can help people with benign duodenal strictures feel better by keeping the narrowed area open and preventing the stent from moving out of place.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: N/A to 75 Years
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06736301 on ClinicalTrials.gov

What this trial studies

This study investigates the use of a double pig-tail stent to assist in the fixation of fully-covered metal stents for patients suffering from benign duodenal strictures. The approach aims to minimize stent displacement and ensure effective expansion of the narrowed duodenal area, thereby alleviating symptoms associated with upper gastrointestinal obstruction. The study will evaluate both the safety and efficacy of this method, providing insights into its long-term effectiveness for treating this condition.

Who should consider this trial

Good fit: Ideal candidates include patients under 75 years old with diagnosed benign duodenal strictures who have experienced symptoms of upper gastrointestinal obstruction and have not responded to multiple balloon dilations.

Not a fit: Patients with gastrointestinal perforation, malignant strictures, or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve symptom relief and quality of life for patients with benign duodenal strictures.

How similar studies have performed: While this specific approach is novel, similar studies using stent-assisted techniques have shown promise in managing gastrointestinal strictures.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Fully Covered Metal Stents — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Changqing Sun

Conditions Benign Duodenal Stricture; duodenal stricture; fully covered stent