Rectal Neuroendocrine Tumor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREUEMR procedure
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.
PROCEDUREESD procedure
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.
Sponsors
Nanfang Hospital, Southern Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
The Eighth Affiliated Hospital of Southern Medical University
ZhuHai Hospital
Shenzhen Longgang District People's Hospital
Jiangmen Central Hospital
Yangjiang People's Hospital
The Third People's Hospital of Huizhou
the Fifth Affiliated Hospital of Zunyi Medical University (Zhuhai)
Ganzhou City People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 to 75 years; 2. With a high suspicion or evidence of rectal NET assessed using EUS, CT scan or colonoscopy; 3. With tumor size ≤10 mm assessed by colonoscopy or EUS; 4. Plan to receive UEMR or ESD treatment and provide written informed consent.
Exclusion criteria
1. Unable to tolerate ESD or UEMR as assessed by the research team; 2. 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; 3. Rectal NET with lymph node metastasis or distant metastasis; 4. Received resection of rectal neuroendocrine tumor by other surgical procedures; 5. Multiple rectal neuroendocrine tumors; 6. Vulnerable groups such as pregnant women or patients with mental disorders; 7. Poor compliance, unable to cooperate with treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histological complete resection | within 14 days after procedure | complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success rate of operation | intraoperative | the proportion of patients whose tumors were successfully resected in each group |
| en bloc resection | intraoperative | complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined |
| operation time | intraoperative | 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 | within 14 days after procedure | perforation or hemorrhage during or after operation. |
| length of stay | within 14 days after procedure | calculated from the day of admission to day of discharge |
| operation cost | within 14 days after procedure | the cost of UEMR or ESD procedures, except the cost of other endoscopic procedures |
| hospitalization cost | within 14 days after procedure | represent the hospital's costs of being hospitalized |
| histopathologic grade | within 14 days after procedure | NET grade 1, NET grade 2, NET grade 3, and NEC |
Countries
China
Contacts
CONTACTZelong Han, MD
CONTACTBitao Lin, MD
Outcome results
None listed