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LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Recruiting
18-75 years
All
Phase N/A

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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.

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)

Eligibility

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 details
    Hepatic Flexure Colon Cancer
    Proximal Transverse Colon Cancer

NCT05923255

Zhejiang University

23 March 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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