NCT02942238

Brief Summary

To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

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

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

October 20, 2016

Last Update Submit

December 20, 2016

Conditions

Overall SurvivalPostoperative ComplicationsMetastasisStage, Colon Cancer

Keywords

CMERight hemi Colon cancerD3laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    3 years

Secondary Outcomes (4)

  • The rate of postoperative complications and mortality

    30 days

  • 3 years overall survival

    3 years

  • The rate of local and distant recurrence

    3 years

  • The accuracy of preoperative staging with CT

    14 days

Study Arms (2)

Complete Mesocolic Excision

EXPERIMENTAL

the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.

Procedure: CME

D3 lymph node dissection

ACTIVE COMPARATOR

the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group.

Procedure: D3

Interventions

CMEPROCEDURE

the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed. Intervention: Procedure: Complete mesocolic excision (CME)

Complete Mesocolic Excision
D3PROCEDURE

the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels. Intervention: Procedure: D3 radical operation

D3 lymph node dissection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suitable for curative surgery 18-75years old
  • Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
  • Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
  • Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
  • 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

Related Publications (9)

  • Ostenfeld EB, Erichsen R, Iversen LH, Gandrup P, Norgaard M, Jacobsen J. Survival of patients with colon and rectal cancer in central and northern Denmark, 1998-2009. Clin Epidemiol. 2011;3 Suppl 1(Suppl 1):27-34. doi: 10.2147/CLEP.S20617. Epub 2011 Jul 21.

    PMID: 21814467RESULT

  • Laparoscopically assisted colectomy is as safe and effective as open colectomy in people with colon cancer Abstracted from: Nelson H, Sargent D, Wieand HS, et al; for the Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050-2059. Cancer Treat Rev. 2004 Dec;30(8):707-9. doi: 10.1016/j.ctrv.2004.09.001. No abstract available.

    PMID: 15541580RESULT

  • Kitano S, Inomata M, Sato A, Yoshimura K, Moriya Y; Japan Clinical Oncology Group Study. Randomized controlled trial to evaluate laparoscopic surgery for colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404. Jpn J Clin Oncol. 2005 Aug;35(8):475-7. doi: 10.1093/jjco/hyi124. Epub 2005 Jul 8.

    PMID: 16006574RESULT

  • Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.

    PMID: 15894098RESULT

  • Engstrom PF, Arnoletti JP, Benson AB 3rd, Chen YJ, Choti MA, Cooper HS, Covey A, Dilawari RA, Early DS, Enzinger PC, Fakih MG, Fleshman J Jr, Fuchs C, Grem JL, Kiel K, Knol JA, Leong LA, Lin E, Mulcahy MF, Rao S, Ryan DP, Saltz L, Shibata D, Skibber JM, Sofocleous C, Thomas J, Venook AP, Willett C; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: colon cancer. J Natl Compr Canc Netw. 2009 Sep;7(8):778-831. doi: 10.6004/jnccn.2009.0056. No abstract available.

    PMID: 19755046RESULT

  • West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.

    PMID: 22473170RESULT

  • Kobayashi H, West NP, Takahashi K, Perrakis A, Weber K, Hohenberger W, Quirke P, Sugihara K. Quality of surgery for stage III colon cancer: comparison between England, Germany, and Japan. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S398-404. doi: 10.1245/s10434-014-3578-9. Epub 2014 Feb 25.

    PMID: 24566862RESULT

  • Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.

    PMID: 25555421RESULT

  • Eiholm S, Ovesen H. Total mesocolic excision versus traditional resection in right-sided colon cancer - method and increased lymph node harvest. Dan Med Bull. 2010 Dec;57(12):A4224.

    PMID: 21122462RESULT

MeSH Terms

Conditions

Postoperative ComplicationsNeoplasm MetastasisColonic Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal 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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

December 1, 2022

Last Updated

December 21, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share