LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Official title

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

Overview

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).

Interventions

• 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.

Primary outcome measures

• 3-year disease free survival [Time frame: 3 years]

Secondary outcome measures (6)

• Perioperative complications [Time frame: up to 30 days after surgery]
• Quality of the specimen [Time frame: up to 2 weeks after surgery]
• Incidence rates of polyps and adenomas [Time frame: 5 years]
• Scores of quality of life [Time frame: 3 years]
• Scores from the EQ-5D-5L Quality of Life Scale [Time frame: 3 years]
• 5-year overall survival rate (OS) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

• Age between 18-75 years old
• ASA classification ≤III
• Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
• 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)
• Preoperative clinical staging: TanyNanyM0
• Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent

Exclusion criteria

• Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
• 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
• Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
• 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
• Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
• Patients unsuitable for or unable to tolerate laparoscopic surgery
• Pregnant or lactating women
• Patients with a history of psychiatric disorders
• Patients who have received neoadjuvant therapy prior to surgery
• Patients deemed unsuitable for the study by MDT discussion
• Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 29 centers

• the First Affiliated Hospital of Bengbu Medical Collage — Bengbu
• Beijing Cancer Hospital — Beijing
• Peking Union Medical College Hospital — Beijing
• Cancer Hospital Academy of medicine Scenice — Beijing
• the First Affiliated Hospital of Chongqing Medical Collage — Chongqing
• Fujian Cancer Hospital — Fuzhou
• Fujian Hospital Medical Union University — Fuzhou
• The First Affiliated Hospital of Xiamen University — Xiamen
• … and 21 more centers

Identifiers

NCT: NCT05923255 · CRCCZ-S03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗