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Clinical Trials/NCT03982264
NCT03982264
Unknown
Not Applicable

Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm

Nanfang Hospital, Southern Medical University0 sites90 target enrollmentJune 20, 2019
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ConditionsRectal Neuroendocrine Tumor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Neuroendocrine Tumor
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
90
Primary Endpoint
complete resection rate(R0 rate)
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.

Registry
clinicaltrials.gov
Start Date
June 20, 2019
End Date
December 20, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age from 18 to 75 years;
  • •Definite diagnosis of rectal NET less than 10mm;
  • •Patients plan to receive either EMR-C or ESD treatment.

Exclusion Criteria

  • •Serious comorbid diseases such as advanced malignant tumor and organ failure;
  • •Patients received conventional EMR, snare electrotomy and no treatment;
  • •Rectal NET with metastasis;
  • •Pregnant patient;
  • •Poor compliance

Outcomes

Primary Outcomes

complete resection rate(R0 rate)

Time Frame: within 14 days after procedure

Complete resection was defined as negative horizontal and vertical margins of specimen.

Secondary Outcomes

  • operating time(intraoperative)
  • hospitalization cost(within 14 days after procedure)
  • complications rate(within 14 days after procedure)
  • length of stay(within 14 days after procedure)
  • recurrence rate(one year after procedure)

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