NCT05923255

LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 568 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the long-term outcomes of Laparoscopic Ileocecal-Sparing Right Hemicolectomy(LISH) compared to traditional laparoscopic right hemicolectomy(TRH) in the treatment of hepatic flexure colon cancer and proximal transverse colon cancer.

Detailed description

This study is a prospective, multicenter, open-labeled, randomized controlled clinical trial. The enrolled patients will be randomly assigned to either the LISH or TRH group in a 1:1 ratio and will receive the corresponding surgery. The primary endpoint: 3-year disease free survival. The second endpoint: 30-day perioperative complications, pathological outcomes (specimen quality, positive resection margin rate, number of lymph nodes retrieved, and lymph node positivity rate), histological prognostic indicators (planned for superiority testing: 1-, 3-, and 5-year rates of newly detected polyps and adenomas on colonoscopy), quality of life (planned for superiority testing: Gastrointestinal Symptom Rating Scale \[GSRS\] score and EQ-5D-5L score), and 5-year overall survival (OS).

Conditions

• Hepatic Flexure Colon Cancer
• Proximal Transverse Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）	Preserve the ileocolic blood vessels, and perform dissection of lymph node groups 203, 202, and 201d along the root of ICV(Ileocolic artery)/ICA(Ileocolic vein). Group 201d lymph nodes are defined as the distal lymph nodes of the ileocolic vessels (colonic branch). Use an intracavitary cutting and sealing device to transect the proximal colon along the predetermined margin, and transect the transverse colon at 10cm distal to the tumor. Perform ileocecal-transverse colonic anastomosis.
PROCEDURE	TRH（Traditional Laparoscopic Right Hemicolectomy）	Transect the root of the ileocolic vessels and perform dissection of lymph node groups 203, 202, and 201; sever the roots of the right colic and middle colic vessels, and clear the surrounding lymphoadipose tissue (lymph node groups 211/212/213 and 221/222/223). Transect the transverse colon 10cm distal to the tumor and cut the terminal ileum 10cm from the ileocecal junction. Perform ileum-to-transverse colon anastomosis.

Timeline

• Start date: 2023-05-14
• Primary completion: 2026-05-14
• Completion: 2031-05-14
• First posted: 2023-06-28
• Last updated: 2026-01-27

Locations

29 sites across 1 country: China