Clinical trial NCT06001476: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Peutz-Jeghers Syndrome
Small Bowel Polyp
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS
timeFrame: 28 days after the procedure
Secondary outcomes:
measure: Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy
timeFrame: Immediately after the procedure
measure: Incidence of complications within 28 days after enteroscopy
timeFrame: 28 days after the procedure
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
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