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

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ClinicalTrials.gov Identifier: NCT03982264
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 11, 2019
Estimated Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
complete resection rate(R0 rate) [ Time Frame: within 14 days after procedure ]
Complete resection was defined as negative horizontal and vertical margins of specimen.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • operating time [ Time Frame: intraoperative ]
    the time from endoscope in to endoscope out
  • complications rate [ Time Frame: within 14 days after procedure ]
    Complications were defined as perforation or hemorrhage during or after operation.
  • length of stay [ Time Frame: within 14 days after procedure ]
    calculated from the day of admission to day of discharge
  • hospitalization cost [ Time Frame: within 14 days after procedure ]
    represent the hospital's costs of being hospitalized
  • recurrence rate [ Time Frame: one year after procedure ]
    a new rectal NET recurred confirmed by endoscopy and EUS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
Official Title  ICMJE Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Neuroendocrine Tumor
Intervention  ICMJE
  • Procedure: ESD procedure
    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.
  • Procedure: EMR-C procedure
    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.
Study Arms  ICMJE
  • Active Comparator: ESD group
    In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET
    Intervention: Procedure: ESD procedure
  • Experimental: EMR-C group
    In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET
    Intervention: Procedure: EMR-C procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2021
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982264
Other Study ID Numbers  ICMJE NFEC-2017-077
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanfang Hospital of Southern Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP