ClinicalTrials.gg
Not yet recruitingNCT06001476Updated Aug 21, 2023

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

A Phase 4 interventional study of Cold snare polypectomy in Peutz-Jeghers Syndrome and Small Bowel Polyp, sponsored by Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 8 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Shandong University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
8 Years to 60 Years
Sex
All
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Study 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.

02

Conditions studied

  • Peutz-Jeghers Syndrome
  • Small Bowel Polyp

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03

In context

Peutz-Jeghers Syndrome

22 studies on the registry are indexed under Peutz-Jeghers Syndrome; 8 are open to participants now.

Browse Peutz-Jeghers Syndrome studies →

Lead sponsor

Shandong University is the lead sponsor of 292 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Cold snare polypectomy group

    Procedure: Cold snare polypectomy

Interventions

  • ProcedureCold snare polypectomy

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

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What researchers measure

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

    Time frame: 28 days after the procedure

Secondary outcomes

  1. 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.

    Time frame: Immediately after the procedure

  2. Incidence of complications within 28 days after enteroscopy

    Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.

    Time frame: 28 days after the procedure

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 31342472 ↗
  • 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. PubMed 28212588 ↗
  • 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. PubMed 28970290 ↗
  • 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. PubMed 21704992 ↗
  • 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. PubMed 31099986 ↗
  • 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. PubMed 27629953 ↗
  • 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. PubMed 27126203 ↗
  • 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. PubMed 28493238 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2023; primary completion for Dec 2024, 16 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2023
First posted
Aug 21, 2023
StartEst.
Aug 20, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Feb 1, 2025
Last update
Aug 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06001476
Responsible party
Xiuli Zuo (Director of Qilu Hospital gastroenterology department, Shandong University) — Principal investigator
First posted
Aug 21, 2023
Start date
Aug 20, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Aug 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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