Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Hepatic Flexure and Proximal Transverse Colon Cancers

Overview

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

Full Title of Study: “An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Hepatic Flexure and Proximal Transverse Colon Cancers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2022

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Conversion to conventional right hemicolectomy
    • Time Frame: 1 day of surgery
    • the rate of conversion to conventional right hemicolectomy
  • Time to first flatus after surgery
    • Time Frame: up to 7 days after surgery
    • days from a colectomy procedure to first occurrence of flatus during subject’s postoperative recovery
  • Number of harvested lymph nodes
    • Time Frame: up to 1 week after surgery
    • Number of harvested Lymph nodes according to the pathological report
  • R0 resection
    • Time Frame: up to 1 week after surgery
    • Rate of resection without any affected margins during the surgical procedure according to the pathological report
  • Specimen morphometry
    • Time Frame: within 30 days
    • The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ding Ke-Feng, Professor – Zhejiang University
  • Overall Official(s)
    • KeFeng Ding, PhD, Principal Investigator, Zhejiang University
  • Overall Contact(s)
    • Kefeng Ding, PhD, 008613906504783, dingkefeng@zju.edu.cn

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