LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Zhejiang University

Status: Enrolling

Conditions: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer

Treatments: Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy）; Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）

Study type: Interventional

Funder types: Other

Identifiers

NCT05923255

CRCCZ-S03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 568 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18-75 years old
2. ASA classification ≤III
3. Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
4. Enhanced abdominal CT indicating the primary lesion is located in the hepatic flexure of the colon or proximal transverse colon (proximal 1/3 of the transverse colon)
5. Preoperative clinical staging: TanyNanyM0
6. Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent

Exclusion criteria

1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
2. Preoperative imaging or intraoperative exploration reveals: 1) tumor involving surrounding organs requiring combined organ resection; 2) presence of distant metastasis; 3) inability to perform R0 resection; 4) fused and fixed lymph nodes at the root of the ileocolic vessels
3. Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
4. History of any other malignant tumor within the last 5 years or familial adenomatous polyposis, except for cured in situ cervical cancer, basal cell carcinoma, papillary thyroid carcinoma, or skin squamous cell carcinoma
5. Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
6. Patients unsuitable for or unable to tolerate laparoscopic surgery
7. Pregnant or lactating women
8. Patients with a history of psychiatric disorders
9. Patients who have received neoadjuvant therapy prior to surgery
10. Patients deemed unsuitable for the study by MDT discussion
11. Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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568 participants in 2 patient groups

LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group

Experimental group

Description:

In LISH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing a novel radical right hemicolectomy technique that allows for the preservation of the ileocecal region.

Treatment:

Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）

TRH （Traditional Right Hemicolectomy）group

Active Comparator group

Description:

In TRH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing the traditional radical right hemicolectomy.

Treatment:

Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy）