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

NCT ID: NCT04479111

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-01-01

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

Conditions

Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

laparoscopic ileocecus-sparing right hemicolectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Ding Ke-Feng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KeFeng Ding, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CRCCZ-S02

Identifier Type: -

Identifier Source: org_study_id