NCT02625272

Brief Summary

The purpose of this study is to determine the short and long outcomes of the novel technique of hand-assisted laparoscopic right hemicolectomy with complete mesocolic excision and central vascular ligation for right colon 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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_2

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

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2.4 years

First QC Date

December 1, 2015

Last Update Submit

November 7, 2017

Conditions

Colon Neoplasms

Keywords

hand-assisted laparoscopic surgeryright colon cancercomplete mesocolic excisionno touch isolationrecurrenceoverall survival

Outcome Measures

Primary Outcomes (2)

  • operative time

    1 day

  • the content RNA of CEA and CK20 in circulating tumor cells and ascites

    1 week

Secondary Outcomes (4)

  • postoperative complications

    1 year

  • overall survival

    3 years

  • disease-free survival

    3 years

  • 3-year local recurrence

    3 years

Study Arms (3)

Group A

EXPERIMENTAL

The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.

Procedure: Group A

Group B

NO INTERVENTION

novel laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were divided at the beginning of the operation intracorporeally.

Group C

NO INTERVENTION

the traditional laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer.

Interventions

Group APROCEDURE

The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.

Group A

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed right colon cancer
  • Clinical stage: I, II, III
  • No preoperative chemoradiotherapy
  • No past surgical history
  • No serious preoperative complication
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
  • Age: 18-80
  • Written informed consent

You may not qualify if:

  • Malignant neoplasm of other sites (including transverse, descending, sigmoid colon cancer, and rectal cancer)
  • Metastatic cancer
  • Multiple cancer
  • Serious complications (including bowel perforation, bowel obstruction, gastrointestinal hemorrhage)
  • Pregnant and lactating women
  • Psychological disorder
  • Steroid administration
  • Cardiac infarction within six months
  • Severe pulmonary emphysema and pulmonary fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (22)

  • Peters WR, Bartels TL. Minimally invasive colectomy: are the potential benefits realized? Dis Colon Rectum. 1993 Aug;36(8):751-6. doi: 10.1007/BF02048366.

    PMID: 8348865BACKGROUND

  • Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy AM; COlon cancer Laparoscopic or Open Resection Study Group (COLOR). Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol. 2005 Jul;6(7):477-84. doi: 10.1016/S1470-2045(05)70221-7.

    PMID: 15992696BACKGROUND

  • Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.

    PMID: 19071061BACKGROUND

  • Naitoh T, Gagner M, Garcia-Ruiz A, Heniford BT, Ise H, Matsuno S. Hand-assisted laparoscopic digestive surgery provides safety and tactile sensation for malignancy or obesity. Surg Endosc. 1999 Feb;13(2):157-60. doi: 10.1007/s004649900928.

    PMID: 9918620BACKGROUND

  • Meijer DW, Bannenberg JJ, Jakimowicz JJ. Hand-assisted laparoscopic surgery: an overview. Surg Endosc. 2000 Oct;14(10):891-5. doi: 10.1007/s004640020019.

    PMID: 11080398BACKGROUND

  • Aalbers AG, Biere SS, van Berge Henegouwen MI, Bemelman WA. Hand-assisted or laparoscopic-assisted approach in colorectal surgery: a systematic review and meta-analysis. Surg Endosc. 2008 Aug;22(8):1769-80. doi: 10.1007/s00464-008-9857-4. Epub 2008 Apr 24.

    PMID: 18437486BACKGROUND

  • Chung CC, Ng DC, Tsang WW, Tang WL, Yau KK, Cheung HY, Wong JC, Li MK. Hand-assisted laparoscopic versus open right colectomy: a randomized controlled trial. Ann Surg. 2007 Nov;246(5):728-33. doi: 10.1097/SLA.0b013e318123fbdf.

    PMID: 17968162BACKGROUND

  • Kusminsky RE, Boland JP, Tiley EH. Hand-assisted laparoscopic surgery. Dis Colon Rectum. 1996 Jan;39(1):111. doi: 10.1007/BF02048280. No abstract available.

    PMID: 8601348BACKGROUND

  • Handoscopic surgery: a prospective multicenter trial of a minimally invasive technique for complex abdominal surgery. Southern Surgeons' Club Study Group. Arch Surg. 1999 May;134(5):477-85; discussion 485-6.

    PMID: 10323419BACKGROUND

  • Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.

    PMID: 19016817BACKGROUND

  • Petrovic T, Radovanovic Z, Breberina M, et al. Complete mesocolic excision with central supplying vessel ligation- new technique in colon cancer treatment. Arch Oncol, 2010; 18(3) : 84- 85.

    BACKGROUND

  • West NP, Hohenberger W, Weber K, Perrakis A, Finan PJ, Quirke P. Complete mesocolic excision with central vascular ligation produces an oncologically superior specimen compared with standard surgery for carcinoma of the colon. J Clin Oncol. 2010 Jan 10;28(2):272-8. doi: 10.1200/JCO.2009.24.1448. Epub 2009 Nov 30.

    PMID: 19949013BACKGROUND

  • West NP, Morris EJ, Rotimi O, Cairns A, Finan PJ, Quirke P. Pathology grading of colon cancer surgical resection and its association with survival: a retrospective observational study. Lancet Oncol. 2008 Sep;9(9):857-65. doi: 10.1016/S1470-2045(08)70181-5. Epub 2008 Jul 28.

    PMID: 18667357BACKGROUND

  • 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: 22473170BACKGROUND

  • Feng B, Sun J, Ling TL, Lu AG, Wang ML, Chen XY, Ma JJ, Li JW, Zang L, Han DP, Zheng MH. Laparoscopic complete mesocolic excision (CME) with medial access for right-hemi colon cancer: feasibility and technical strategies. Surg Endosc. 2012 Dec;26(12):3669-75. doi: 10.1007/s00464-012-2435-9. Epub 2012 Jun 26.

    PMID: 22733200BACKGROUND

  • Adamina M, Manwaring ML, Park KJ, Delaney CP. Laparoscopic complete mesocolic excision for right colon cancer. Surg Endosc. 2012 Oct;26(10):2976-80. doi: 10.1007/s00464-012-2294-4. Epub 2012 May 2.

    PMID: 22549374BACKGROUND

  • Takemasa I, Uemura M, Nishimura J, Mizushima T, Yamamoto H, Ikeda M, Sekimoto M, Doki Y, Mori M. Feasibility of single-site laparoscopic colectomy with complete mesocolic excision for colon cancer: a prospective case-control comparison. Surg Endosc. 2014 Apr;28(4):1110-8. doi: 10.1007/s00464-013-3284-x. Epub 2013 Nov 8.

    PMID: 24202709BACKGROUND

  • Storli KE, Sondenaa K, Furnes B, Eide GE. Outcome after introduction of complete mesocolic excision for colon cancer is similar for open and laparoscopic surgical treatments. Dig Surg. 2013;30(4-6):317-27. doi: 10.1159/000354580. Epub 2013 Sep 10.

    PMID: 24022524BACKGROUND

  • BARNES JP. Physiologic resection of the right colon. Surg Gynecol Obstet. 1952 Jun;94(6):722-6. No abstract available.

    PMID: 14931182BACKGROUND

  • Turnbull RB Jr, Kyle K, Watson FR, Spratt J. Cancer of the colon: the influence of the no-touch isolation technic on survival rates. Ann Surg. 1967 Sep;166(3):420-7. doi: 10.1097/00000658-196709000-00010. No abstract available.

    PMID: 6039601BACKGROUND

  • Wiggers T, Jeekel J, Arends JW, Brinkhorst AP, Kluck HM, Luyk CI, Munting JD, Povel JA, Rutten AP, Volovics A, et al. No-touch isolation technique in colon cancer: a controlled prospective trial. Br J Surg. 1988 May;75(5):409-15. doi: 10.1002/bjs.1800750505.

    PMID: 3292002BACKGROUND

  • Yang X, Wu Q, Jin C, He W, Wang M, Yang T, Wei M, Deng X, Meng W, Wang Z. A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial. Trials. 2017 Jul 26;18(1):355. doi: 10.1186/s13063-017-2084-3.

    PMID: 28747220DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ziqiang Wang, MD,PhD

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziqiang Wang, MD,PhD

CONTACT

+8618980602028wangzqzyh@163.com

Xuyang Yang, MD

CONTACT

+8618280456901yangxuyang15@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Gastrointestinal Surgery

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 9, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2017

Study Completion

April 1, 2020

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

CN(1)