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.
Researchers plan to conduct a prospective, multicenter, non-inferiority, randomized controlled trial to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET in ten endoscopic centers in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Small 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.
Small 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.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGhistological 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
success rate of operation
the proportion of patients whose tumors were successfully resected in each group
Time frame: intraoperative
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
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
Time frame: intraoperative
complications
perforation or hemorrhage during or after operation.
Time frame: within 14 days after procedure
length of stay
calculated from the day of admission to day of discharge
Time frame: within 14 days after procedure
operation cost
the cost of UEMR or ESD procedures, except the cost of other endoscopic procedures
Time frame: within 14 days after procedure
hospitalization cost
represent the hospital's costs of being hospitalized
Time frame: within 14 days after procedure
histopathologic grade
NET grade 1, NET grade 2, NET grade 3, and NEC
Time frame: within 14 days after procedure
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