Benign Duodenal StrictureNCT06736301
Double Pig Tail Stent-assisted Fixation of Fully Covered Metal Stents for the Treatment of Benign Duodenal Strictures
A study testing a fully covered stent in people with Benign Duodenal Stricture, run by Shupei Li at 1 site in China.
Trial summary
Double Pig Tail Stent-assisted Fixation of Fully-Covered Metal Stents for the Treatment of Benign Duodenal Strictures Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Benign Duodenal Stricture
- What is being tested?
- a fully covered stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fully Covered Metal Stents
Nanjing, Jiangsu, 210000
Changqing Sun, 18851675250, 18851675250@163.com
About this study
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
Double Pig Tail Stent-assisted Fixation of Fully-Covered Metal Stents for the Treatment of Benign Duodenal Strictures
Read the 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.
- Conditions
- Benign Duodenal Stricture
- Being tested
- a fully covered stent
- Keywords
- duodenal stricture, fully covered stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a fully covered stentDevice
a double pig-tail stent for cross fixation of a fully covered stent
| Study group | Role | What they receive |
|---|---|---|
| stent | Experimental | a double pig-tail stent for cross fixation of a fully covered stent Receives: Device: a fully covered stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 30 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 Dec 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Duodenal StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shupei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shupei Li, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736301
- Sponsor's protocol ID
- DZQH-KYLL-24-40
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06736301
- Acronym / sponsor ID
- DZQH-KYLL-24-40
- Conditions
- Benign Duodenal Stricture
- Keywords
- duodenal stricture, fully covered stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shupei LiUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stent | Experimental | Device: a fully covered stenta double pig-tail stent for cross fixation of a fully covered stent |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a fully covered stenta double pig-tail stent for cross fixation of a fully covered stent | Device | stent |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a fully covered stent in people with Benign Duodenal Stricture, run by Shupei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changqing Sun (18851675250, 18851675250@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate at 30 days post-operation (time frame: at 30 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.