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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03982264
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
Rectal Neuroendocrine Tumor Procedure: ESD procedure Procedure: EMR-C procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: ESD group
In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET
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.

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. operating time [ Time Frame: intraoperative ]
    the time from endoscope in to endoscope out

  2. complications rate [ Time Frame: within 14 days after procedure ]
    Complications were defined as perforation or hemorrhage during or after operation.

  3. length of stay [ Time Frame: within 14 days after procedure ]
    calculated from the day of admission to day of discharge

  4. hospitalization cost [ Time Frame: within 14 days after procedure ]
    represent the hospital's costs of being hospitalized

  5. recurrence rate [ Time Frame: one year after procedure ]
    a new rectal NET recurred confirmed by endoscopy and EUS

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Nanfang Hospital of Southern Medical University Identifier: NCT03982264    
Other Study ID Numbers: NFEC-2017-077
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue