NCT03349788

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.

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
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

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

First Submitted

Initial submission to the registry

November 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 5, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

November 9, 2017

Last Update Submit

December 2, 2017

Conditions

Overall SurvivalPostoperative Complications

Keywords

Left colic arteryLaparoscopic SurgeryAnterior resection of rectumRectum cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    3 years

Secondary Outcomes (4)

  • The rate of postoperative coml[ications and mortality

    30 days

  • 3 years overall survival

    3 years

  • The rate of local and distant recurrence

    3 years

  • The rate of LN.253 metastasis

    2 weeks

Study Arms (2)

LCA-nP

EXPERIMENTAL

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.

Procedure: LCA-nP

LCA-P

ACTIVE COMPARATOR

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.

Procedure: LCA-P

Interventions

LCA-nPPROCEDURE

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

LCA-nP
LCA-PPROCEDURE

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

LCA-P

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, 200000, China

Location

Related Publications (9)

  • Lange MM, Buunen M, van de Velde CJ, Lange JF. Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A review. Dis Colon Rectum. 2008 Jul;51(7):1139-45. doi: 10.1007/s10350-008-9328-y. Epub 2008 May 16.

    PMID: 18483828BACKGROUND

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PMID: 25651787RESULT

  • Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.

    PMID: 24225001RESULT

  • Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.

    PMID: 26537907RESULT

  • Uehara K, Yamamoto S, Fujita S, Akasu T, Moriya Y. Impact of upward lymph node dissection on survival rates in advanced lower rectal carcinoma. Dig Surg. 2007;24(5):375-81. doi: 10.1159/000107779. Epub 2007 Aug 4.

    PMID: 17785983RESULT

  • 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

  • Kim HJ, Kim CH, Lim SW, Huh JW, Kim YJ, Kim HR. An extended medial to lateral approach to mobilize the splenic flexure during laparoscopic low anterior resection. Colorectal Dis. 2013 Feb;15(2):e93-8. doi: 10.1111/codi.12056.

    PMID: 23061515RESULT

  • Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.

    PMID: 25623323RESULT

  • Titu LV, Tweedle E, Rooney PS. High tie of the inferior mesenteric artery in curative surgery for left colonic and rectal cancers: a systematic review. Dig Surg. 2008;25(2):148-57. doi: 10.1159/000128172. Epub 2008 Apr 29.

    PMID: 18446037RESULT

MeSH Terms

Conditions

Postoperative ComplicationsRectal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Minhua Zheng, PhD

    Ruijin Hospital

    STUDY DIRECTOR

Central Study Contacts

Minhua Zheng, PhD

CONTACT

+86-13564119545zmhtiger@yeah.net

Hiju Hong, PhD Student

CONTACT

+86-13564119545jing12722@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 22, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

December 5, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)