Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • mEMR-C procedure

    Procedure/Surgery

    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.

  • ESD procedure

    Procedure/Surgery

    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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: mEMR-C groupExperimental treatment 1 intervention
Group B: ESD groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

histological complete resection

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

Time frame
within 14 days after procedure

Secondary outcomes

1

success rate of operation

the proportion of patients whose tumors were successfully resected in each group

Time frame
intraoperative
2

en bloc resection

complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined

Time frame
intraoperative
3

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

Time frame
intraoperative
4

complications

perforation or hemorrhage during or after operation.

Time frame
within 14 days after procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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