Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome

Peutz-Jeghers Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06001476
• Other study ID #: 2023-SDU-QILU-G002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 20, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: August 2023
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Polyps
• Peutz-Jeghers Syndrome
• Polyps
• Syndrome

Intervention

Procedure:
• Cold snare polypectomy
For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled, broad-pedicled or sessile small bowel polyps

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17. — View Citation

Hamada K, Takeuchi Y, Ishikawa H, Tonai Y, Matsuura N, Ezoe Y, Ishihara R, Tomita Y, Iishi H. Feasibility of Cold Snare Polypectomy for Multiple Duodenal Adenomas in Patients with Familial Adenomatous Polyposis: A Pilot Study. Dig Dis Sci. 2016 Sep;61(9):2755-9. doi: 10.1007/s10620-016-4165-7. Epub 2016 Apr 28. No abstract available. — View Citation

Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28. — View Citation

Maruoka D, Matsumura T, Kasamatsu S, Ishigami H, Taida T, Okimoto K, Nakagawa T, Katsuno T, Arai M. Cold polypectomy for duodenal adenomas: a prospective clinical trial. Endoscopy. 2017 Aug;49(8):776-783. doi: 10.1055/s-0043-107028. Epub 2017 May 10. — View Citation

Sakamoto H, Yamamoto H, Hayashi Y, Yano T, Miyata T, Nishimura N, Shinhata H, Sato H, Sunada K, Sugano K. Nonsurgical management of small-bowel polyps in Peutz-Jeghers syndrome with extensive polypectomy by using double-balloon endoscopy. Gastrointest Endosc. 2011 Aug;74(2):328-33. doi: 10.1016/j.gie.2011.04.001. Epub 2011 Jun 25. — View Citation

Sato J, Hirooka Y, Watanabe O, Nakamura M, Yamamura T, Funasaka K, Ohno E, Kawashima H, Miyahara R, Goto H. Newly Developed Endoscopic Treatment for Small Bowel Polyps: Cold Snare Polypectomy. Intern Med. 2016;55(18):2601-3. doi: 10.2169/internalmedicine.55.6732. Epub 2016 Sep 15. — View Citation

van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23. — View Citation

Wang YX, Bian J, Zhu HY, Dong YH, Fang AQ, Li ZS, Du YQ. The role of double-balloon enteroscopy in reducing the maximum size of polyps in patients with Peutz-Jeghers syndrome: 12-year experience. J Dig Dis. 2019 Aug;20(8):415-420. doi: 10.1111/1751-2980.12784. Epub 2019 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days after the procedure
Secondary	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.	Immediately after the procedure
Secondary	Incidence of complications within 28 days after enteroscopy	Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.	28 days after the procedure