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Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Primary Purpose

Rectal Neuroendocrine Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mEMR-C procedure
ESD procedure
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neuroendocrine Tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age from 18 to 75 years;
  2. With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
  3. With tumor size ≤10 mm assessed by colonoscopy;
  4. Plan to receive mEMR-C or ESD treatment and provide written informed consent;

Exclusion Criteria:

  1. Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
  2. Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
  3. Rectal NET with lymph node metastasis or distant metastasis;
  4. Received resection of rectal neuroendocrine tumor by other surgical procedures;
  5. Multiple rectal neuroendocrine tumors;
  6. Vulnerable groups such as pregnant women or patients with mental disorders;
  7. Poor compliance, unable to cooperate with treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    mEMR-C group

    ESD group

    Arm Description

    In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection.

    In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the rectal NET

    Outcomes

    Primary Outcome Measures

    histological complete resection
    complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.

    Secondary Outcome Measures

    success rate of operation
    the proportion of patients whose tumors were successfully resected in each group
    en bloc resection
    complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined
    operation time
    the time required to complete the procedure, was taken from the installation of the snare in the mEMR-C or the first submucosal injection in ESD to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation
    complications
    perforation or hemorrhage during or after operation.
    length of stay
    calculated from the day of admission to day of discharge
    hospitalization cost
    represent the hospital's costs of being hospitalized
    operation cost
    the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures
    histopathologic grade
    NET grade 1, NET grade 2, NET grade 3, and NEC

    Full Information

    First Posted
    June 17, 2022
    Last Updated
    June 27, 2022
    Sponsor
    Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05429216
    Brief Title
    Endoscopic Resection for Small Rectal Neuroendocrine Tumors
    Official Title
    Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanfang Hospital, Southern Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.
    Detailed Description
    Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six tertiary hospitals in China.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Neuroendocrine Tumor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mEMR-C group
    Arm Type
    Experimental
    Arm Description
    In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection.
    Arm Title
    ESD group
    Arm Type
    Active Comparator
    Arm Description
    In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the rectal NET
    Intervention Type
    Procedure
    Intervention Name(s)
    mEMR-C procedure
    Intervention Description
    A transparent cap with an inner groove (MH-593; Olympus, Tokyo, Japan) was attached to the forward-viewing colonoscope. After the endoscope was inserted into the rectum, a crescent-shaped electrosurgical snare was passed through the sheath and looped along the inner groove of the cap. Submucosal injections were not required in this method. The tumor was suctioned into the cap and grasped by tightening the snare. After confirming the appropriate snare placement, both the tumor and overlying mucosa were resected using electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and the resected tumor was sent for pathological examination. Endoscopic examination was repeated without a transparent cap to evaluate the wound carefully in cases of perforation or bleeding and to ensure the absence of residual tumor tissues. If there was spurting or active bleeding, hot forceps were used to stop the bleeding.
    Intervention Type
    Procedure
    Intervention Name(s)
    ESD procedure
    Intervention Description
    ESD was performed as the standard procedure and has been widely described and used. First, dots were marked approximately 5 mm from the periphery of the lesion using coagulation. Subsequently, a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. Mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan). After resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding.
    Primary Outcome Measure Information:
    Title
    histological complete resection
    Description
    complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.
    Time Frame
    within 14 days after procedure
    Secondary Outcome Measure Information:
    Title
    success rate of operation
    Description
    the proportion of patients whose tumors were successfully resected in each group
    Time Frame
    intraoperative
    Title
    en bloc resection
    Description
    complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined
    Time Frame
    intraoperative
    Title
    operation time
    Description
    the time required to complete the procedure, was taken from the installation of the snare in the mEMR-C or the first submucosal injection in ESD to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation
    Time Frame
    intraoperative
    Title
    complications
    Description
    perforation or hemorrhage during or after operation.
    Time Frame
    within 14 days after procedure
    Title
    length of stay
    Description
    calculated from the day of admission to day of discharge
    Time Frame
    within 14 days after procedure
    Title
    hospitalization cost
    Description
    represent the hospital's costs of being hospitalized
    Time Frame
    within 14 days after procedure
    Title
    operation cost
    Description
    the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures
    Time Frame
    within 14 days after procedure
    Title
    histopathologic grade
    Description
    NET grade 1, NET grade 2, NET grade 3, and NEC
    Time Frame
    within 14 days after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age from 18 to 75 years; With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy; With tumor size ≤10 mm assessed by colonoscopy; Plan to receive mEMR-C or ESD treatment and provide written informed consent; Exclusion Criteria: Unable to tolerate ESD or MEMR-C as assessed by the research team of each center; Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation; Rectal NET with lymph node metastasis or distant metastasis; Received resection of rectal neuroendocrine tumor by other surgical procedures; Multiple rectal neuroendocrine tumors; Vulnerable groups such as pregnant women or patients with mental disorders; Poor compliance, unable to cooperate with treatment.

    12. IPD Sharing Statement

    Learn more about this trial

    Endoscopic Resection for Small Rectal Neuroendocrine Tumors

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