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NCT Number: NCT05923255

LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

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.

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Key information

Conditions

Hepatic Flexure Colon Cancer Proximal Transverse Colon Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Bengbu Medical Collage, Bengbu, Anhui, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）

Procedure

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.

TRH（Traditional Laparoscopic Right Hemicolectomy）

Procedure

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 outcomes

  1. 3-year disease free survival

    Time frame: 3 years

    the time from enrollment until disease relapse or death from any cause 3 years after surgery

Secondary outcomes

  1. Perioperative complications

    Time frame: up to 30 days after surgery

    Complications occurring within 30 days after surgery. Perioperative complications are classified according to the Clavien-Dindo classification system and include intraoperative, short-term, and long-term postoperative complications. The following events are considered serious perioperative complications: hemorrhage requiring transfusion of >4 units of packed red blood cells; postoperative complications necessitating emergent surgical intervention; severe infection (as defined by the American College of Chest Physicians/Society of Critical Care Medicine 1992 criteria); and deaths attributable to the surgical procedure. These should be reported within 30 days postoperatively.

  2. Quality of the specimen

    Time frame: up to 2 weeks after surgery

    The data included specimen quality, positive margin rate, number of harvested lymph nodes and positive lymph nodes

  3. Incidence rates of polyps and adenomas

    Time frame: 5 years

    the incidence rates of polyps and adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.

  4. Scores of quality of life

    Time frame: 3 years

    measured by scores from the Gastrointestinal Symptom Rating Scale (GSRS) at 1, 2, and 3 years after surgery respectively, and scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.

  5. Scores from the EQ-5D-5L Quality of Life Scale

    Time frame: 3 years

    scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.

  6. 5-year overall survival rate (OS)

    Time frame: 5 years

    The proportion of patients who survived 5 years after surgery, taking into account any cause of death.

Other outcomes

  1. Conversion Rate from Laparoscopic to Open Surgery

    Time frame: Intraoperative period

    The proportion of laparoscopic surgeries that are converted to open surgeries due to intraoperative complications, technical challenges, or other clinical reasons.

  2. LISH Surgery Completion Rate

    Time frame: Intraoperative period

    The proportion of patients in whom the LISH procedure is successfully completed without conversion to TRH or other alternative surgical approaches.

  3. Minimal Residual Disease (MRD) via Circulating Tumor DNA (ctDNA)

    Time frame: Preoperative (7 days), postoperative (7 days), and 3 months post-surgery

    Detection of MRD using circulating tumor DNA (ctDNA) as a biomarker.

  4. Short- and Long-Term Changes in Gut Microecology

    Time frame: Preoperative, postoperative 3 months, 6 months and 12 months

    Analysis of gut microbiota, epithelial cells, stromal cells, immune cells, and metabolic products using fecal samples and intestinal biopsy tissues.

  5. Glycemic Metabolic Indicators - Hemoglobin A1c (HbA1c)

    Time frame: Preoperative, 3 months, 6 months, and 12 months post-surgery

    Measurement of glycated hemoglobin (HbA1c) levels to assess long-term glycemic control.

  6. Oral Glucose Tolerance Test (OGTT)

    Time frame: Preoperative, 3 months, 6 months, and 12 months post-surgery

    Evaluation of glucose metabolism by measuring blood glucose and insulin levels at 0, 30, 60, 120 minutes after oral glucose administration.

  7. Insulin Resistance (HOMA-IR)

    Time frame: Preoperative, 3 months, 6 months, and 12 months post-surgery

    Calculation of insulin sensitivity using fasting glucose and insulin levels

Study contacts

Contact information is provided by the study sponsor or research team.

Kefeng Ding, PhD

CONTACT

[email protected]

86-571-87784720

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Jun 28, 2023
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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