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Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

Primary Purpose

Overall Survival, Postoperative Complications

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

LCA-nP

LCA-P

About this trial

This is an interventional treatment trial for Overall Survival focused on measuring Left colic artery, Laparoscopic Surgery, Anterior resection of rectum, Rectum cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged more then 18 years old;
Diagnosed as rectal cancer with colonoscopic biopsy;
Without metastasis;
No Invasion of surrounding tissues;
Limited operation;
Underwent laparoscopic radical proctectomy(L-Dixon);
BMI 18~30kg/m2;
Without multiple primary tumors;
Sign on the Medical informed Consent.

Exclusion Criteria:

Simultaneous or simultaneous multiple primary colorectal cancer;
Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
History of any other malignant tumor in recent 5 years;
Patients need emergency operation;
Not suitable for laparoscopic surgery;
Women during Pregnancy or breast feeding period;
Informed consent refusal

Sites / Locations

Shanghai Ruijin Hospttal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCA-nP

LCA-P

Arm Description

The group underwent laparoscopic radical rectectomy without preserving left colic artery. In IMA group, the dissecting based on TME is performed without preserving left colic artery. Surgeon should dissect the lymph nodes and ligated the vessel in the root of inferior mesenteric artery.

The group underwent laparoscopic radical rectectomy with preserving left colic artery. In LCA group, the dissecting based on TME is performed with preserving left colic artery. The relationship of inferior mesenteric artery, inferior mesenteric vein and LCA should be identified and ligated separately without LCA.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

The rate of postoperative coml[ications and mortality

3 years overall survival

The rate of local and distant recurrence

The rate of LN.253 metastasis

Full Information

NCT ID

NCT03349788

First Posted

November 9, 2017

Last Updated

December 2, 2017

Sponsor

Shanghai Minimally Invasive Surgery Center

1. Study Identification

Unique Protocol Identification Number

NCT03349788

Brief Title

Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

Official Title

Randomized Controlled Trial: Clinical Value of Preserving Left Colic Artery in Laparoscopic Radical Rectectomy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Anticipated)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Minimally Invasive Surgery Center

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

Colorectal cancer is one of the most common tumors in Asia. According to the recent research, surgical procedure could provide more treatment benefit in rectal cancer. Therefore, it was consider that important to standardized and improved the surgical procedure for rectal cancer. With the development of anatomical technique, minimally surgery with laparoscopy had become the trend for surgical treatment. There were several studies has been done to evaluate the safety and feasibility of laparoscopic surgery. In order to achieve better surgical outcome and reduce operative complications, the investigators design stratified randomization, double blinded, muti - center clinical trail to investigate the value of left colic artery in laparoscopic radical rectectomy.

6. Conditions and Keywords

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

Overall Survival, Postoperative Complications

Keywords

Left colic artery, Laparoscopic Surgery, Anterior resection of rectum, Rectum cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LCA-nP

Arm Type

Experimental

Arm Description

Arm Title

LCA-P

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

LCA-nP

Intervention Description

The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.

Intervention Type

Procedure

Intervention Name(s)

LCA-P

Intervention Description

The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.

Primary Outcome Measure Information:

Title

Disease-free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

The rate of postoperative coml[ications and mortality

Time Frame

30 days

Title

3 years overall survival

Time Frame

3 years

Title

The rate of local and distant recurrence

Time Frame

3 years

Title

The rate of LN.253 metastasis

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged more then 18 years old; Diagnosed as rectal cancer with colonoscopic biopsy; Without metastasis; No Invasion of surrounding tissues; Limited operation; Underwent laparoscopic radical proctectomy(L-Dixon); BMI 18~30kg/m2; Without multiple primary tumors; Sign on the Medical informed Consent. Exclusion Criteria: Simultaneous or simultaneous multiple primary colorectal cancer; Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection; History of any other malignant tumor in recent 5 years; Patients need emergency operation; Not suitable for laparoscopic surgery; Women during Pregnancy or breast feeding period; Informed consent refusal

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minhua Zheng, PhD

Phone

+86-13564119545

zmhtiger@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Hiju Hong, PhD Student

Phone

+86-13564119545

jing12722@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minhua Zheng, PhD

Organizational Affiliation

Ruijin Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Ruijin Hospttal

City

Shanghai

State/Province

Sahgnhai

ZIP/Postal Code

200000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18483828

Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Citation

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Citation

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

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