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

Primary Purpose

Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

laparoscopic ileocecus-sparing right hemicolectomy

About this trial

This is an interventional treatment trial for Hepatic Flexure Colon Cancer focused on measuring hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Second Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LISRH group

Arm Description

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.

Outcomes

Primary Outcome Measures

Postoperative complications

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

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,

Secondary Outcome Measures

Conversion to conventional right hemicolectomy

the rate of conversion to conventional right hemicolectomy

Time to first flatus after surgery

days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery

Number of harvested lymph nodes

Number of harvested Lymph nodes according to the pathological report

R0 resection

Rate of resection without any affected margins during the surgical procedure according to the pathological report

Specimen morphometry

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

3-year disease free survival

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

Full Information

NCT ID

NCT04479111

First Posted

July 16, 2020

Last Updated

February 7, 2023

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04479111

Brief Title

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

Acronym

LISH

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 30, 2022 (Actual)

Study Completion Date

January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer

Keywords

hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LISRH group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

laparoscopic ileocecus-sparing right hemicolectomy

Intervention Description

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 Outcome Measure Information:

Title

Postoperative complications

Description

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

Time Frame

up to 90 days after surgery

Title

1-year local recurrence

Description

rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,

Time Frame

7 days after surgery

Secondary Outcome Measure Information:

Title

Conversion to conventional right hemicolectomy

Description

the rate of conversion to conventional right hemicolectomy

Time Frame

1 day of surgery

Title

Time to first flatus after surgery

Description

days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery

Time Frame

up to 7 days after surgery

Title

Number of harvested lymph nodes

Description

Number of harvested Lymph nodes according to the pathological report

Time Frame

up to 1 week after surgery

Title

R0 resection

Description

Rate of resection without any affected margins during the surgical procedure according to the pathological report

Time Frame

up to 1 week after surgery

Title

Specimen morphometry

Description

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

Time Frame

within 30 days

Title

3-year disease free survival

Description

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

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KeFeng Ding, PhD

Organizational Affiliation

Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Affiliated Hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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