About this trial
Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Therefore, we aimed to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 75 years;
With a high suspicion or evidence of rectal NET assessed using EUS, CT scan or colonoscopy;
With tumor size ≤10 mm assessed by colonoscopy or EUS;
Plan to receive UEMR or ESD treatment and provide written informed consent.
Disqualifiers
Unable to tolerate ESD or UEMR as assessed by the research team;
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
Parallel
Treatments tested in this trial
UEMR procedure
Procedure/SurgerySmall rectal NET will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3)needle injection of normal saline into the submucosa; (4) snaring the lesion and the surrounding mucosa; and (5) resection using electrocautery.
ESD procedure
Procedure/SurgerySmall rectal NET will be removed by endoscopic submucosal dissection. The ESD procedure included the following: (1) dots were marked approximately 5 mm from the periphery of the lesion using coagulation; (2) a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. (3) mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan); (4)after resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding.
Treatment groups
Trial outcomes
Primary outcomes
histological complete resection
complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.
Secondary outcomes
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 first submucosal injection 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.
Sponsors and contacts
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Nanfang Hospital, Southern Medical University
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
The Eighth Affiliated Hospital of Southern Medical University
Collaborator
ZhuHai Hospital
Collaborator
Shenzhen Longgang District People's Hospital
Collaborator
Jiangmen Central Hospital
Collaborator
Yangjiang People's Hospital
Collaborator
The Third People's Hospital of Huizhou
Collaborator
the Fifth Affiliated Hospital of Zunyi Medical University (Zhuhai)
Collaborator
Ganzhou City People's Hospital
Collaborator