Rectal Neuroendocrine Tumors
Conditions
Interventions
ESMR-DL group:The procedure includes endoscopic localization of the R-NET lesion
submucosal injection at the base of the lesion using glycerol fructose solution or normal saline containing a small amount of indigo carmine and diluted epinephrine to lift the lesion and surrounding
placement of a multiband ligation device, negative-pressure suction of the lesion into the transparent cap, and deployment of the first band
downward compression of the cap along the formed pseudopolyp toward the basal side, followed by a second negative-pressure suction to capture deeper submucosal tissue and deployment of the second band
and final placement of a high-frequency snare below the second band to resect the lesion en bloc after confirming that the muscularis propria is not entrapped. The wound will routinely be closed proph
ESD group:The procedure includes careful observation of tumor margins under white-light and chromoendoscopy
marking 3-5 mm outside the lesion margin on normal mucosa
submucosal injection to separate the lesion from the muscularis propria
circumferential mucosal incision along the outside of the marks using a dedicated endoscopic dissection knife
layer-by-layer submucosal dissection under direct vision with cap assistance, with dissection close to the muscularis propria underneath the lesion to ensure complete resection
and treatment of exposed vessels after en bloc resection, with wound closure using endoscopic clips when appropriate. ESD will be performed by experienced endoscopists with independent colorectal ESD
the protocol spe
Sponsors
Wenzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with rectal neuroendocrine tumors diagnosed by endoscopy; 2. Maximum tumor diameter of 10 mm or less, based on endoscopic measurement; 3. Age 18 to 80 years, regardless of sex; 4. Patients with early-stage R-NETs of G1 or G2 grade and low malignant potential; 5. Voluntary participation with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Suspected invasion of the muscularis propria, lymph node involvement, or distant metastasis; 2. Previous endoscopic treatment at the same lesion site, such as EMR or polypectomy; 3. Use of antithrombotic therapy, such as aspirin, clopidogrel, or warfarin, that cannot be discontinued according to the protocol requirement, usually 5-7 days before the procedure; 4. Pregnancy or lactation; 5. Severe cardiac, cerebral, pulmonary, hepatic, or renal dysfunction that makes the patient unable to tolerate endoscopic treatment; 6. Any other condition judged by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total procedure time;Incidence of serious complications during the procedure and within 28 days after the procedure;Total medical cost;Vertical margin depth / vertical margin distance;Overall adverse event rate; | — |
Countries
China
Contacts
Public ContactLin Jiejun
Wenzhou Central Hospital
Outcome results
None listed