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

Hepatic Flexure Colon Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479111
• Other study ID #: CRCCZ-S02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Hepatic Flexure Colon Cancer
• Proximal Transverse Colon Cancer

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded	up to 90 days after surgery
Primary	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	Conversion to conventional right hemicolectomy	the rate of conversion to conventional right hemicolectomy	1 day of surgery
Secondary	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
Secondary	Number of harvested lymph nodes	Number of harvested Lymph nodes according to the pathological report	up to 1 week after surgery
Secondary	R0 resection	Rate of resection without any affected margins during the surgical procedure according to the pathological report	up to 1 week after surgery
Secondary	Specimen morphometry	The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length	within 30 days
Secondary	3-year disease free survival	the time from enrollment until disease relapse or death from any cause 3 years after surgery	3 years