Rectal Neuroendocrine Tumors
Conditions
Interventions
Experimental group:Simplified Endoscopic Mucosal Resection Without Submucosal Injection
Sponsors
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adult subjects aged 18-80 years old, regardless of gender; 2. Patients diagnosed with rectal neuroendocrine tumors (rectal NET) by colonoscopy and scheduled for endoscopic treatment; 3. The endoscopic examination can basically determine that the lesion is limited to the mucosa or submucosa, and no obvious deep infiltration is observed. If it is difficult to determine during the endoscopy, the operator can decide to perform EUS; 4. The maximum diameter of the lesion is <= 10 mm (measured by endoscopy or EUS); 5. The general condition of the subjects can tolerate endoscopic treatment; 6. The subjects or their legal representatives voluntarily participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Preoperative endoscopic assessment shows that the maximum diameter of the lesion is greater than 10mm, or the endoscopic appearance indicates that the lesion range significantly exceeds the conventional mucosal/submucosal resection range; 2. The same site of rectal NET has undergone endoscopic or surgical resection in the past, and this is for the treatment of the stump/recurrence; 3. Endoscopy, EUS, or other imaging and nuclear medicine examinations suggest that it may involve the muscularis propria or have obvious lymph node enlargement/transfer tendency; 4. Concurrent other digestive tract malignancies or high-grade lesions (such as colorectal cancer, advanced polyps, etc.) that require priority treatment; 5. High-risk of bleeding and unable to stop anticoagulant/antiplatelet drugs as per the standard, such as those who need to continue using dual antiplatelet or warfarin/DOAC and cannot discontinue or bridge; 6. Severe coagulation dysfunction (such as INR > 1.5, platelet < 50×10^9/L) or active bleeding disorders; 7. Severe heart, lung, liver, or kidney dysfunction, unable to tolerate intestinal preparation or endoscopic treatment; 8. Pregnant or lactating women; 9. Complicated with active inflammatory bowel disease, severe perianal diseases, etc., which affect rectal treatment or healing; 10. Unable to cooperate with follow-up or expected to be long-term absent during the follow-up period and unable to complete the research plan and clinical and endoscopic reexamination; 11. Other situations that the investigator considers not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 Resection Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Perforation Rate;Intraoperative Bleeding Rate;Device Cost;Tumor-to-Margin Distance;The incidence of postoperative complications (such as delayed bleeding, infection, etc.);Operation Time;Recurrent rate (e.g. when the follow-up period is >= 6 months); | — |
Countries
China
Contacts
Public ContactWang Qiang
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Outcome results
None listed