Back to resultsCold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome
Primary Purpose
Peutz-Jeghers Syndrome, Small Bowel Polyp
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cold snare polypectomy
Sponsored by
About this trial
This is an interventional treatment trial for Peutz-Jeghers Syndrome
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.
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cold snare polypectomy group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS
The complications include complications during CSP and complications occurring within 28 days after enteroscopy
Secondary Outcome Measures
Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy
Including intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.
Incidence of complications within 28 days after enteroscopy
Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06001476
Brief Title
Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome
Official Title
Feasibility and Safety Analysis of Cold Snare Polypectomy in 5-9mm Small Intestinal Polyp Resection in Patients With Peutz-Jeghers Syndrome: A Prospective, Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peutz-Jeghers Syndrome, Small Bowel Polyp
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold snare polypectomy group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cold snare polypectomy
Intervention Description
For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled, broad-pedicled or sessile small bowel polyps
Primary Outcome Measure Information:
Title
Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS
Description
The complications include complications during CSP and complications occurring within 28 days after enteroscopy
Time Frame
28 days after the procedure
Secondary Outcome Measure Information:
Title
Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy
Description
Including intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.
Time Frame
Immediately after the procedure
Title
Incidence of complications within 28 days after enteroscopy
Description
Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.
Time Frame
28 days after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
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Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome
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