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EMR Versus CSP in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size

ConditionColorectal Sessile Serrated Lesion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorFudan University

About this trial

A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 35 and 75 years

Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy

0-Is or 0-IIa according to Paris classification

Type 1 according to NICE and JNET classification

Disqualifiers

Unsuitable for removal by EMR or CSP

Suspected dysplasia or malignancy

Recurrent sessile serrated lesions after endoscopic resection

Familial adenomatous polyposis, Lynch syndrome or serrated polyposis syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic mucosal resection

    Procedure/Surgery

    The SSLs less than 10mm in size in this group will be treated by EMR

  • Cold snare polypectomy

    Procedure/Surgery

    The SSLs less than 10mm in size in this group will be treated by CSP

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: EMR in treating SSLs less than 10mm in sizeExperimental treatment 1 intervention
Group B: CSP in treating SSLs less than 10mm in sizeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

R0 resection

Rate of R0 resection in treating SSLs less than 10mm in size

Time frame
2 weeks after the procedure

Secondary outcomes

1

en bloc resection

Rate of en bloc resection rate in treating SSLs less than 10mm in size

Time frame
immediately after the procedure
2

Vertical margins

Rate of negative vertical margins in resected specimen

Time frame
2 weeks after the procedure
3

Lateral margin

Rate of negative lateral margin in resected specimen

Time frame
2 weeks after the procedure
4

Presence of muscularis mucosae

Rate of presence of muscularis mucosae in resected specimen

Time frame
2 weeks after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: