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Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm

Primary Purpose

Rectal Neuroendocrine Tumor

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESD procedure
EMR-C 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:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    ESD group

    EMR-C group

    Arm Description

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

    In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET

    Outcomes

    Primary Outcome Measures

    complete resection rate(R0 rate)
    Complete resection was defined as negative horizontal and vertical margins of specimen.

    Secondary Outcome Measures

    operating time
    the time from endoscope in to endoscope out
    complications rate
    Complications were defined as 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
    recurrence rate
    a new rectal NET recurred confirmed by endoscopy and EUS

    Full Information

    First Posted
    June 5, 2019
    Last Updated
    June 10, 2019
    Sponsor
    Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03982264
    Brief Title
    Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
    Official Title
    Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 20, 2019 (Anticipated)
    Primary Completion Date
    December 20, 2020 (Anticipated)
    Study Completion Date
    December 20, 2021 (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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    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
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESD group
    Arm Type
    Active Comparator
    Arm Description
    In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET
    Arm Title
    EMR-C group
    Arm Type
    Experimental
    Arm Description
    In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET
    Intervention Type
    Procedure
    Intervention Name(s)
    ESD procedure
    Intervention Description
    ESD were all performed as the standard procedure that has been widely described and used. A diluted sodium hyaluronate solution was injected submucosally. Mucosal incision and submucosal dissection were performed by using either Hook knife (Olympus Medical, Japan) or a dual-knife (Olympus Medical, Japan) . After the resection was finished, all of the visible vessels on the artificial ulcer bed were thoroughly coagulated with argon plasma coagulation to prevent postoperative bleeding.
    Intervention Type
    Procedure
    Intervention Name(s)
    EMR-C procedure
    Intervention Description
    A transparent cap (MH-593; Olympus) was attached to the forward-viewing endoscope. After the endoscope was inserted to the rectum, the snare passed through the sheath and was looped along the inner lip of the cap. The tumor was then suctioned into the cap and the snare was pushed off and closed. After confirming the appropriate snare placement, both the tumor and the overlying mucosa were resected by electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and then the removed tumor was sent for pathological examination. Endoscopic examination then was repeated without the transparent cap in order to evaluate the wound carefully in case there was any perforation or bleeding and to ensure the absence of the residual tumor tissues. If there was spurting bleeding or active bleeding, hot forceps were usually to stop the bleeding.
    Primary Outcome Measure Information:
    Title
    complete resection rate(R0 rate)
    Description
    Complete resection was defined as negative horizontal and vertical margins of specimen.
    Time Frame
    within 14 days after procedure
    Secondary Outcome Measure Information:
    Title
    operating time
    Description
    the time from endoscope in to endoscope out
    Time Frame
    intraoperative
    Title
    complications rate
    Description
    Complications were defined as 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
    recurrence rate
    Description
    a new rectal NET recurred confirmed by endoscopy and EUS
    Time Frame
    one year 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; 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

    12. IPD Sharing Statement

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    Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm

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