Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon (LISH)

An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon

To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

Study Overview

• Status: Completed
• Conditions: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer
• Intervention / Treatment: Procedure: laparoscopic ileocecus-sparing right hemicolectomy

Detailed Description

Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients suitable for curative surgery 18-75years old
2. ASA grade I-III
3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
4. Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
6. Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm.
7. Informed consent

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
3. Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
4. Distant metastasis.
5. History of any other malignant tumor in recent 5 years.
6. Patients need emergency operation.
7. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
8. Informed consent refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: LISRH group; Following the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies.

Procedure: laparoscopic ileocecus-sparing right hemicolectomy; The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded	up to 90 days after surgery
1-year local recurrence	rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to conventional right hemicolectomy	the rate of conversion to conventional right hemicolectomy	1 day of surgery
Time to first flatus after surgery	days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery	up to 7 days after surgery
Number of harvested lymph nodes	Number of harvested Lymph nodes according to the pathological report	up to 1 week after surgery
R0 resection	Rate of resection without any affected margins during the surgical procedure according to the pathological report	up to 1 week after surgery
Specimen morphometry	The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length	within 30 days
3-year disease free survival	the time from enrollment until disease relapse or death from any cause 3 years after surgery	3 years

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Principal Investigator: KeFeng Ding, PhD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): December 30, 2022
• Study Completion (ACTUAL): January 1, 2023

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (ACTUAL): July 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic right hemicolectomy; hepatic flexure colon cancer; proximal transverse colon cancer; ileocecus-sparing
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CRCCZ-S02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No