Comparative study of two endoscopic resection techniques (anchored snare-tip vs. precut endoscopic mucosal resection) for the treatment of rectal neuroendocrine turmos smaller than 10 mm in size
- Conditions
- Neoplasms
- Registration Number
- KCT0005148
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Results Seventy-five NETs in 73 patients, including 64 eligible lesions (32 by EMR-P and 32 by Tip-in EMR) were evaluated. The median size of NET by endoscopy was 5.0 mm in the EMR-P group and 6.0 mm in the Tip-in EMR group. In the modified intention-to-treat analysis, R0 resection of the EMR-P group and that of the Tip-in EMR group were 96.9% and 90.6%, respectively (risk difference, -6.3 [95% CI -18.0–5.5]). The resection time in the EMR-P group was longer than that in the Tip-in EMR group (5.0 vs. 2.9 minutes, P<0.001), whereas the post-procedure processing time was similar (2.1 vs. 2.4 minutes, P=0.651). Only one case of complication, immediate postprocedural bleeding, was reported in both arms. The histopathology of the resected specimens in each group will be re-evaluated by the pathologist specialized in neuroendocrine tumors, and the final results can be updated accordingly.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
? Patients who will undergo endoscopic treatment for an established or suspected rectal neuroendocrine tumor (NET)
? Patients with an age of 20 to 79 years
? Patients who provided informed consent for this study.
? An established or suspected rectal NET larger than or equal to 10 mm in endoscopically measured size.
? A incompletely resected rectal NET after a previous therapeutic endoscopic interventio that requires endoscopic submucosal dissection, instead of EMR or modified EMR techniques.
? Without trying precut EMR or ASEMR (interventions for this study), endoscopic submucosal dissection was performed because of the inadequate lifting of the lesion after submucosal injection
? Platelet count less than 80,000/uL or Prolonged PT (over 50%) in the laboratory tests checked within 6 months before the intervention.
? Medical history of other known coagulopathy
? Patients who do not provide informed consent for this study
? Patients who do not show on the scheduled date for intervention and do not undergo the assigned intervention.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Histologic complete resection rate (per protocol analysis: only include rectal NETs in the final histologic report)
- Secondary Outcome Measures
Name Time Method Procedure completion rate (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Resection time (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Procedure time including endoscopic hemostasis time (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Adverse event rate (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis)