NCT06901856

Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Modified Cap-assisted Endoscopic Mucosal Resection and Modified Endoscopic Mucosal Resection with a Ligation Device for Small Rectal Neuroendocrine Tumors Less Than 1 Cm: a Muticenter Randomized Noninferiority Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rectal Neuroendocrine Tumor

Interventions

Type	Name	Description
PROCEDURE	mEMR-C 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.
PROCEDURE	mEMR-L 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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-01
• Completion: 2027-10-01
• First posted: 2025-03-30
• Last updated: 2025-03-30