LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Not Applicable

Recruiting

• Conditions: Proximal Transverse Colon Cancer; Hepatic Flexure Colon Cancer

• Registration Number: NCT05923255
• Lead Sponsor: Zhejiang University

Brief 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: (1)90-day postoperative complications; (2)Pathology-related indicators, including positive margin rate, number of harvested lymph nodes and lymph node metastasis rate;(3) 5-year overall survival rate (OS)

Study Timeline

• Study Start: 2023-05-14
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-05-14
• Study Completion: 2031-05-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 568

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
3-year disease free survival	3 years	the time from enrollment until disease relapse or death from any cause 3 years after surgery

Secondary Outcome Measures

Name	Time	Method
Length of resected specimen	up to 2 weeks after surgery	On the basis of the anterior and posterior photographs, the length of resected specimen were measured.
Postoperative complications	up to 30 days after surgery	Complications occurring within 30 days after surgery, classified according to the Clavien-Dindo system, including intraoperative, short-term, and long-term postoperative complications.Index (CCI) will be recorded
Metastasis rate of harvested lymph nodes	up to 2 weeks after surgery	according to the pathological report
Quality of CME (complete mesocolic excision)	up to 2 weeks after surgery	After the specimen had been harvested, photographs of the anterior and posterior aspects of the specimens were uploaded to the electronic data capture system. On the basis of the anterior and posterior photographs, the specimens were classified into three groups of the quality of CME: grade I, intact mesocolon; grade II laceration in the mesocolon; and grade III laceration in the mesocolon reaching the bowel.
Incidence rates of polyps	5 years	the incidence rates of polyps as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.
Scores from the Gastrointestinal Symptom Rating Scale (GSRS)	3 years	scores from the Gastrointestinal Symptom Rating Scale (GSRS) at 1, 2, and 3 years after surgery respectively.
Scores from the EQ-5D-5L Quality of Life Scale	3 years	scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.
Resection margins distance	up to 2 weeks after surgery	On the basis of the anterior and posterior photographs, the distal and proximal resection margins distance of the resected intestinal specimen were measured.
Vascular pedicle length of resected specimen	up to 2 weeks after surgery	On the basis of the anterior and posterior photographs, the vascular pedicle length of the resected intestinal specimen were measured.
Positive margin rate	up to 2 weeks after surgery	positive margin rate of resected specimen according to the pathological report
Incidence rates of adenomas	5 years	the incidence rates of adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.
5-year overall survival rate (OS)	5 years	The proportion of patients who survived 5 years after surgery, taking into account any cause of death.

Trial Locations

Locations (34)

Guangdong Second Provincial General Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

the First Affiliated Hospital of Bengbu Medical Collage; 🇨🇳 Bengbu, Anhui, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital Academy of medicine Scenice; 🇨🇳 Beijing, Beijing, China

the First Affiliated Hospital of Chongqing Medical Collage; 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Scroll for more (24 remaining)