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Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)

This study is currently recruiting participants.
Verified August 2016 by Shan Wang, Peking University People's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724775
First Posted: November 12, 2012
Last Update Posted: August 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shan Wang, Peking University People's Hospital
  Purpose
In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in which the same principle of TME in rectal cancer has been applied to the colon. More and more surgeons pay attention to the rationality of this surgical approach. However, the clinical application researches are still few, in particular the prospective controlled study is still none. This clinical trial will compare the CME group and non-CME group to evaluate the outcome and safety of CME for apply in clinic.

Condition
Colon Cancer Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.

Further study details as provided by Shan Wang, Peking University People's Hospital:

Primary Outcome Measures:
  • Prognosis assessment of postoperative patients [ Time Frame: yearly, up to 5 years ]
    The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.


Secondary Outcome Measures:
  • Safety assessment of the patients in perioperation period [ Time Frame: Daily, up to one month ]
    Includes: postoperative complications, hospital mortality, operative time, blood loss, exhaust time, defecation time, drainage and unplug time, resumed eating time, drainage volume during postoperation three days and so on.


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
CME surgery for colon cancer
non-CME surgery for colon cancer

Detailed Description:

Materials and Methods:

All the patients with colon cancer will undergo elective radical operation. The observations were recorded during the operation and on the postoperative specimens. Intra-operative photographs were taken at various stages, as were photographs of the postoperative specimen. According to the CME operation keypoints, all the photographs will accept third-party assessment of the expert group, while the third-party expert group will not participate in the management of patients. Both of The evaluators and research doctors are double-blind state. The postoperative patients will divided into two groups according to the results of the assessment. The clinical and pathological data of the patients as well as follow-up information will be recorded and collected.

  1. Outcome of CME By comparison to clinicopathologic variables, and precise tissues morphometry of two groups, the prognosis, lymph nodes harvest and removal of the mesocolic area were investigated. Outcomes of interest also include disease-free survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the correlation between mesocolic area and height, weight, body surface area and body mass index.
  2. Safety of CME CME group and non-CME group were compared the differences of security, included operation time, blood loss, postoperation complications, flatus restoring time, defecation restoring time, drainage removal time, Diet restoring time, drainage volume in three days after surgery, hospital deaths, the exhaust time, hospitalization time and hospitalization costs. In addition, the feasibility of CME techniques as the surgical approach of choice for elderly patients was also evaluated.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients of colon caner in China
Criteria

Inclusion Criteria:

  • Clinical diagnosis of colon cancer;
  • Clinical stage Ⅰ ~ Ⅲ;
  • Undergoing colorectal surgery for the first time;
  • Accept laparotomy;
  • Accept radical resection;
  • More than 18 years.

Exclusion Criteria:

  • Emergency surgery;
  • Preoperative neoadjuvant chemoradiotherapy history;
  • Combined with other malignant diseases;
  • Pathological stage Ⅳ patients with colon cancer.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724775


Contacts
Contact: Zhidong Gao, M.D. 15810195892 xiaoya-008@163.com

Locations
China, Beijing
Department of Gastroenterology Surgery, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Zhidong Gao, M.D.    8610-88326600    xiaoya-008@163.com   
Principal Investigator: Yingjiang Ye, M.D. & Ph.D.         
Sponsors and Collaborators
Shan Wang
Investigators
Study Director: Yingjiang Ye, M.D. & Ph.D. Peking University People's Hospital
  More Information

Responsible Party: Shan Wang, Department of Gastrointestinal Surgery, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01724775     History of Changes
Other Study ID Numbers: PKPH-CME
Z121100005312015 ( Other Grant/Funding Number: Science and Technology Project of Bejing, China )
TG-2015-002 ( Other Grant/Funding Number: Capital health development research project )
20130001120064 ( Other Grant/Funding Number: Doctoral Program of Higher Education )
First Submitted: November 4, 2012
First Posted: November 12, 2012
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shan Wang, Peking University People's Hospital:
complete mesocolic excision
colon cancer
efficacy
safety

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases