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Trial Title:
Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome
NCT ID:
NCT06001476
Condition:
Peutz-Jeghers Syndrome
Small Bowel Polyp
Conditions: Official terms:
Peutz-Jeghers Syndrome
Syndrome
Polyps
Intestinal Polyps
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cold snare polypectomy
Description:
For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled,
broad-pedicled or sessile small bowel polyps
Arm group label:
Cold snare polypectomy group
Summary:
This study aims to evaluate the feasibility and safety of Cold snare polypectomy for
removing 5-9mm small intestinal polyps in patients with Peutz-Jeghers Syndrome (PJS),in
order to provide some reference for clinical strategy of endoscopic treatment of small
intestinal polyps in PJS patients, and may prolong the follow-up period of PJS patients
Intervals.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 8-60, male or female.
- Diagnosed with Peutz-Jeghers Syndrome
- Undergo enteroscopy for small bowel polypectomy.
Exclusion Criteria:
- Absence of at least one study polyp (5-9mm stubby pedicle, wide pedicle and sessile
small bowel polyps);
- Be evaluated during enteroscopy for requiring surgical intervention (such as
endoscopically difficult to handle giant polyps, intussusception, etc.)；
- With more than 50 polyps ≥1cm found in this enteroscopy examination;
- The polyp has been confirmed to be malignant by pathology, or highly suspicious of
malignant transformation under endoscopy;
- Receiving anticoagulant therapy during this treatment;
- Unable or unwilling to provide informed consent.
Gender:
All
Minimum age:
8 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital, Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Start date:
August 20, 2023
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Shandong University
Agency class:
Other
Source:
Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001476
