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

NCT06001476 | Unknown Phase 4

• 1 other identifier: 2023-SDU-QILU-G002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peutz-Jeghers Syndrome; Small Bowel Polyp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy

  Immediately after the procedure

• Incidence of complications within 28 days after enteroscopy

  28 days after the procedure

Study Arms (1)

Cold snare polypectomy group

EXPERIMENTAL

Procedure: Cold snare polypectomy

Interventions

Cold snare polypectomy PROCEDURE

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

Cold snare polypectomy group

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-60, male or female.
• Diagnosed with Peutz-Jeghers Syndrome
• Undergo enteroscopy for small bowel polypectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (8)

• 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.

  PMID: 31342472 BACKGROUND

• 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.

  PMID: 28212588 BACKGROUND

• 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.

  PMID: 28970290 BACKGROUND

• 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.

  PMID: 21704992 BACKGROUND

• 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.

  PMID: 31099986 BACKGROUND

• 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.

  PMID: 27629953 BACKGROUND

• 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.

  PMID: 27126203 BACKGROUND

• 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.

  PMID: 28493238 BACKGROUND

MeSH Terms

Conditions

Peutz-Jeghers Syndrome

Condition Hierarchy (Ancestors)

Neoplastic Syndromes, Hereditary; Neoplasms; Intestinal Polyposis; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: August 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

CN (1)