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

Primary Purpose

Rectal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
left colic artery
High ligation
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Rectal Neoplasms, anastomosis, OS, DFS, LCA, laparoscopic surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

left colic artery group

High ligation group

Arm Description

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

Laparoscopic D3 Lymph Node Dissection with high ligation

Outcomes

Primary Outcome Measures

anastomotic leak rate
percentage of patients occuring anastomotic leak within 30 days since surgery
Number of lymph node dissection
Overall survival rate
3 years total survival rate after surgery
disease-free survival rate
3 years disease-free survival rate after surgery

Secondary Outcome Measures

30-day mortality rate

Full Information

First Posted
April 3, 2016
Last Updated
May 10, 2016
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02753465
Brief Title
A Prospective Clinical Study for Laparoscopic D3 Dissection With Preservation of Left Colic Artery in Rectal Cancer
Official Title
A Prospective Randomized Clinical Study for Laparoscopic D3 Lymph Node Dissection With Preservation of Left Colic Artery in Rectal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Rectal Neoplasms, anastomosis, OS, DFS, LCA, laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
left colic artery group
Arm Type
Experimental
Arm Description
Laparoscopic D3 Lymph Node Dissection with preservation of the left colic artery
Arm Title
High ligation group
Arm Type
Active Comparator
Arm Description
Laparoscopic D3 Lymph Node Dissection with high ligation
Intervention Type
Procedure
Intervention Name(s)
left colic artery
Intervention Description
Laparoscopic D3 Lymph Node Dissection with preservation of left colic artery
Intervention Type
Procedure
Intervention Name(s)
High ligation
Intervention Description
Laparoscopic D3 Lymph Node Dissection with ligation above the left colic artery
Primary Outcome Measure Information:
Title
anastomotic leak rate
Description
percentage of patients occuring anastomotic leak within 30 days since surgery
Time Frame
30 days since the date of surgery
Title
Number of lymph node dissection
Time Frame
10 days since the date of surgery
Title
Overall survival rate
Description
3 years total survival rate after surgery
Time Frame
3 years since the date of surgery
Title
disease-free survival rate
Description
3 years disease-free survival rate after surgery
Time Frame
3 years since the date of surgery
Secondary Outcome Measure Information:
Title
30-day mortality rate
Time Frame
within 30 days since the date of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pathological confirmed rectal adenocarcinoma solitary radical resectable tumors tumor located at 5-15cm from the anus Exclusion Criteria: recurrent cases emergency including obstruction, bleeding or perforation severe abdominal adhesions severe malnutrition can not be improved before surgery can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney refractory hypoproteinemia or diabetes mellitus previous or concomitant other cancers the patients performed APR or hartmann surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-Xiang LI, Ph.D
Phone
+86-18017312900
Email
lxx1149@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
LEI LIANG, Ph.D
Phone
+86-18121299307
Email
LLKNIGHT115@163.COM
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SANJUN CAI, DOCTOR
Phone
02164175590
Ext
1108
Email
caisanjun@gmail.com
First Name & Middle Initial & Last Name & Degree
XINXIANG LI, DOCTOR
First Name & Middle Initial & Last Name & Degree
LEI LIANG, DOCTOR

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26042185
Citation
Tanaka J, Nishikawa T, Tanaka T, Kiyomatsu T, Hata K, Kawai K, Kazama S, Nozawa H, Yamaguchi H, Ishihara S, Sunami E, Kitayama J, Watanabe T. Analysis of anastomotic leakage after rectal surgery: A case-control study. Ann Med Surg (Lond). 2015 May 11;4(2):183-6. doi: 10.1016/j.amsu.2015.05.002. eCollection 2015 Jun.
Results Reference
result
PubMed Identifier
22770982
Citation
Cirocchi R, Trastulli S, Farinella E, Desiderio J, Vettoretto N, Parisi A, Boselli C, Noya G. High tie versus low tie of the inferior mesenteric artery in colorectal cancer: a RCT is needed. Surg Oncol. 2012 Sep;21(3):e111-23. doi: 10.1016/j.suronc.2012.04.004. Epub 2012 Jul 6.
Results Reference
result
PubMed Identifier
22513429
Citation
Bonnet S, Berger A, Hentati N, Abid B, Chevallier JM, Wind P, Delmas V, Douard R. High tie versus low tie vascular ligation of the inferior mesenteric artery in colorectal cancer surgery: impact on the gain in colon length and implications on the feasibility of anastomoses. Dis Colon Rectum. 2012 May;55(5):515-21. doi: 10.1097/DCR.0b013e318246f1a2.
Results Reference
result
PubMed Identifier
22071020
Citation
Cirocchi R, Farinella E, Trastulli S, Desiderio J, Di Rocco G, Covarelli P, Santoro A, Giustozzi G, Redler A, Avenia N, Rulli A, Noya G, Boselli C. High tie versus low tie of the inferior mesenteric artery: a protocol for a systematic review. World J Surg Oncol. 2011 Nov 9;9:147. doi: 10.1186/1477-7819-9-147.
Results Reference
result
PubMed Identifier
17082922
Citation
Seike K, Koda K, Saito N, Oda K, Kosugi C, Shimizu K, Miyazaki M. Laser Doppler assessment of the influence of division at the root of the inferior mesenteric artery on anastomotic blood flow in rectosigmoid cancer surgery. Int J Colorectal Dis. 2007 Jun;22(6):689-97. doi: 10.1007/s00384-006-0221-7. Epub 2006 Nov 3.
Results Reference
result
PubMed Identifier
22968068
Citation
Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
Results Reference
result

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

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