NCT02753465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

3.7 years

First QC Date

April 3, 2016

Last Update Submit

May 10, 2016

Conditions

Rectal Neoplasms

Keywords

Rectal NeoplasmsanastomosisOSDFSLCAlaparoscopic surgery

Outcome Measures

Primary Outcomes (4)

  • anastomotic leak rate

    percentage of patients occuring anastomotic leak within 30 days since surgery

    30 days since the date of surgery

  • Number of lymph node dissection

    10 days since the date of surgery

  • Overall survival rate

    3 years total survival rate after surgery

    3 years since the date of surgery

  • disease-free survival rate

    3 years disease-free survival rate after surgery

    3 years since the date of surgery

Secondary Outcomes (1)

  • 30-day mortality rate

    within 30 days since the date of surgery

Study Arms (2)

left colic artery group

EXPERIMENTAL

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

Procedure: left colic artery

High ligation group

ACTIVE COMPARATOR

Laparoscopic D3 Lymph Node Dissection with high ligation

Procedure: High ligation

Interventions

left colic arteryPROCEDURE

Laparoscopic D3 Lymph Node Dissection with preservation of left colic artery

left colic artery group
High ligationPROCEDURE

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

High ligation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathological confirmed rectal adenocarcinoma
  • solitary radical resectable tumors
  • tumor located at 5-15cm from the anus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26042185RESULT

  • 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.

    PMID: 22770982RESULT

  • 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.

    PMID: 22513429RESULT

  • 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.

    PMID: 22071020RESULT

  • 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.

    PMID: 17082922RESULT

  • 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.

    PMID: 22968068RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Xin-Xiang LI, Ph.D

CONTACT

+86-18017312900lxx1149@163.com

LEI LIANG, Ph.D

CONTACT

+86-18121299307LLKNIGHT115@163.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of colorectal surger

Study Record Dates

First Submitted

April 3, 2016

First Posted

April 27, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

CN(1)