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Completed

NCT Number: NCT04479111

Laparoscopic IIeocecus-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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

laparoscopic ileocecus-sparing right hemicolectomy

Procedure

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.

Primary outcomes

  1. Postoperative complications

    Time frame: up to 90 days after surgery

    Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded

  2. 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 outcomes

  1. Conversion to conventional right hemicolectomy

    Time frame: 1 day of surgery

    the rate of conversion to conventional right hemicolectomy

  2. 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

  3. Number of harvested lymph nodes

    Time frame: up to 1 week after surgery

    Number of harvested Lymph nodes according to the pathological report

  4. 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

  5. Specimen morphometry

    Time frame: within 30 days

    The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length

  6. 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

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Acronym: LISH

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2020
Registry last updated
Feb 8, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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