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According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.
We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mEMR-C group | Experimental | In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection. |
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| mEMR-L group | Active Comparator | In mEMR-L group, enrolled patients will receive modified ESMR-L without submucosal injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mEMR-C procedure | Procedure | A transparent cap with an inner groove (MH-593; Olympus, Tokyo, Japan) was attached to the forward-viewing colonoscope. After the endoscope was inserted into the rectum, a crescent-shaped electrosurgical snare was passed through the sheath and looped along the inner groove of the cap. Submucosal injections were not required in this method. The tumor was suctioned into the cap and grasped by tightening the snare. After confirming the appropriate snare placement, both the tumor and overlying mucosa were resected using electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and the resected tumor was sent for pathological examination. Endoscopic examination was repeated without a transparent cap to evaluate the wound carefully in cases of perforation or bleeding and to ensure the absence of residual tumor tissues. If there was spurting or active bleeding, hot forceps were used to stop the bleeding. |
| Measure | Description | Time Frame |
|---|---|---|
| histological complete resection | complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins. | within 14 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of operation | the proportion of patients whose tumors were successfully resected in each group | intraoperative |
| en bloc resection | complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined |
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Inclusion Criteria:
Exclusion Criteria:
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| mEMR-L procedure | Procedure | First, install the ligation device (provided by Jiangsu Gerrit) at the front end of the endoscope. After inserting the endoscope into the rectum, suck the lesion into the ligation device, release the ligator to ligate the lesion. Then, use a snare to resect the lesion below the ligator. Finally, uniformly suture the wound surface with metal clips. |
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| intraoperative |
| operation time | the time required to complete the procedure, was taken from the installation of the snare in the mEMR-C or the first submucosal injection in ESD to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation | intraoperative |
| complications | perforation or hemorrhage during or after operation | within 14 days after procedure |
| length of stay | calculated from the day of admission to day of discharge | within 14 days after procedure |
| hospitalization cost | represent the hospital's costs of being hospitalized | within 14 days after procedure |
| operation cost | the cost of mEMR-C or mEMR-L procedures, except the cost of other endoscopic procedures | within 14 days after procedure |
| histopathologic grade | NET grade 1, NET grade 2, NET grade 3, and NEC | within 14 days after procedure |