A Prospective Clinical Study for Laparoscopic D3 Dissection With Preservation of Left Colic Artery in Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-12-31

Brief Summary

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During surgery for rectal cancer, there is considerable controversy regarding the optimal level of ligation of the inferior mesenteric artery. Several studies have demonstrated the benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to achieve block dissection of lymph node metastases along the root of the inferior mesenteric artery. In contrast, other studies have shown a significant decrease in blood flow after inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia and the long-term outcomes were not significantly different between high ligation of the inferior mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and the left colic artery and the artery was ligated below the left colic artery. In the present clinical trial, the investigators perform laparoscopic surgery with this management strategy in rectal cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer.

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Detailed Description

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During surgery for rectal cancer, there is considerable controversy regarding the optimal level of ligation of the inferior mesenteric artery.There has been a differentiation between a high versus low ligation of the inferior mesenteric artery related to whether or not the ligation is above (high ligation) or below (low ligation) the left colic artery. Several studies have demonstrated the benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to achieve block dissection of lymph node metastases along the root of the inferior mesenteric artery. Excision of the apical lymph node at the root of the inferior mesenteric artery is thought to be necessary for radical resection of rectal cancer because apical lymph node resection contributes to improve lymph node retrieval rates and the accuracy of tumour staging. In contrast, other studies have shown a significant decrease in blood flow after inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia. Patients with high ligation of inferior mesenteric artery had a 3.8 times higher chance of leaking than those with low ligation. Several studies confirmed that the long-term outcomes were not significantly different between high ligation of the inferior mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and left colic artery and the artery was ligated below the left colic artery, which represented a compromise between the high and low ligation. Recently, several studies have described laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectosigmoid colon cancer. However, there are a few reports that describe the clinical outcomes associated with this management strategy. Furthermore, the long-term outcomes for laparoscopic lymphadenectomy around the inferior mesenteric artery with rectal cancer have seldom been reported. In the present clinical trial, the investigators perform laparoscopic surgery with this management strategy in rectal cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer.

Conditions

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Rectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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left colic artery group

Laparoscopic D3 Lymph Node Dissection with preservation of the left colic artery

Group Type EXPERIMENTAL

left colic artery

Intervention Type PROCEDURE

Laparoscopic D3 Lymph Node Dissection with preservation of left colic artery

High ligation group

Laparoscopic D3 Lymph Node Dissection with high ligation

Group Type ACTIVE_COMPARATOR

High ligation

Intervention Type PROCEDURE

Laparoscopic D3 Lymph Node Dissection with ligation above the left colic artery

Interventions

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left colic artery

Laparoscopic D3 Lymph Node Dissection with preservation of left colic artery

Intervention Type PROCEDURE

High ligation

Laparoscopic D3 Lymph Node Dissection with ligation above the left colic artery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. pathological confirmed rectal adenocarcinoma
2. solitary radical resectable tumors
3. tumor located at 5-15cm from the anus

Exclusion Criteria

1. recurrent cases
2. emergency including obstruction, bleeding or perforation
3. severe abdominal adhesions
4. severe malnutrition can not be improved before surgery
5. can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
6. refractory hypoproteinemia or diabetes mellitus
7. previous or concomitant other cancers
8. the patients performed APR or hartmann surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No