LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
Procedure/SurgeryPreserve 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/SurgeryTransect 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.
Treatment groups
568 Participants
are divided into 2 treatment groupsGroup A: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）groupExperimental treatment 1 intervention
Group B: TRH （Traditional Right Hemicolectomy）groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-year disease free survival
the time from enrollment until disease relapse or death from any cause 3 years after surgery
Time frame
3 yearsSecondary outcomes
1
Perioperative complications
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.
Time frame
up to 30 days after surgery2
Quality of the specimen
The data included specimen quality, positive margin rate, number of harvested lymph nodes and positive lymph nodes
Time frame
up to 2 weeks after surgery3
Incidence rates of polyps and adenomas
the incidence rates of polyps and adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.
Time frame
5 years4
Scores of quality of life
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.
Time frame
3 yearsOther outcomes
1
Conversion Rate from Laparoscopic to Open Surgery
The proportion of laparoscopic surgeries that are converted to open surgeries due to intraoperative complications, technical challenges, or other clinical reasons.
Time frame
Intraoperative period2
LISH Surgery Completion Rate
The proportion of patients in whom the LISH procedure is successfully completed without conversion to TRH or other alternative surgical approaches.
Time frame
Intraoperative period3
Minimal Residual Disease (MRD) via Circulating Tumor DNA (ctDNA)
Detection of MRD using circulating tumor DNA (ctDNA) as a biomarker.
Time frame
Preoperative (7 days), postoperative (7 days), and 3 months post-surgery4
Short- and Long-Term Changes in Gut Microecology
Analysis of gut microbiota, epithelial cells, stromal cells, immune cells, and metabolic products using fecal samples and intestinal biopsy tissues.
Time frame
Preoperative, postoperative 3 months, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov