Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer

August 14, 2018 updated by: Mohamed Abdelkhalek, Mansoura University

Complete Mesocolic Excision (CME) With Central Supplying Vessel Ligation (CVL) Compared With Conventional Surgery for Colon Cancer: a Double-blinded Randomized Study

The aim of this study is to compare between complete mesocolic excision with central vascular ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes, surgical outcome and complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer is the third most common human malignant epithelial tumor and still represents the second cause of cancer death in the United States and Europe.

Over the past few decades, there have been significant improvements in the treatment of patients with colonic and rectal cancers. In rectal cancer, the role of earlier diagnosis, improved preoperative staging, neoadjuvant therapy and total mesorectal excision have improved outcomes from oncological and patient recovery perspectives. Of these, arguably the most important for the surgeon was the advent of Total Mesorectal Excision (TME).

Current thinking is that colonic tumors spread via hematogenous, lymphatic, and possibly perineural routes, with the lymphatics anatomically following the arterial supply. Current practice is to excise a proportion of the draining lymphatic bed to accurately stage the cancer and also clear possible lymphatic metastases.

Recently, significant debate has centered on the degree of lymphatic clearance required; several reports have demonstrated improved oncologic outcomes with wider lymphovascular resections compared with current standard practice. Whether these improved outcomes are secondary to improved lymph node yield or an alternative technical effect has not yet been ascertained.

In analogy to total mesorectal excision (TME) for rectal cancer complete mesocolic excision was recently introduced for curative treatment of colon cancer. Like TME, CME aims at complete en bloc clearance of the lymphatic drainage of the tumor enveloped in intact fascias of embryologic origin.

Based on total mesorectal excision experience, further investigations of the importance of complete mesocolic excision and central vascular ligation surgery for colonic cancer were done by comparing a series of complete mesocolic excision and central vascular ligation specimens from Erlangen, Germany to standard excisions from Leeds, United Kingdom. Lymph node yields, tissue morphometry, and grading the plane of surgery were used to investigate differences between the techniques that could potentially explain the relative differences in survival.

The group from Erlangen in Germany have advocated for CME in conjunction with central vascular ligation for colon cancer. Complete mesocolic excision is reported to differ from traditional colon cancer surgery by achieving a far more radical excision of the lymphovascular pedicle and mesocolon. In addition, the complete mesocolic excision technique promotes resection of the specimen with an intact visceral peritoneum together with proximal and distal resection margins of at least 10 cm. Arterial supply to the affected segment of bowel is taken at its origin from the superior mesenteric artery (right and transverse colon) and the aorta (left colon), described as central vascular ligation. Complete mesocolic excision has been shown to lead to increased lymph node harvest and more mesocolic tissue.

In a comparison between the Leeds and Erlangen units, it was shown that complete mesocolic excision led to an almost doubling in both the number of lymph nodes retrieved and area of mesentery resected. However, a Danish study showed only a 9% increase in lymph node yield.

Surgical concept of complete mesocolic excision represents sharp separation of the undamaged visceral fascia of mesocolon from parietal fascia of peritoneum and the end goal is mobilization of mesocolon and the approach to the appropriate vascular bundle. The scope of surgical intervention depends on localization of the tumor itself. In case that the tumor is located in the right colon next to caecum and ascending colon, it also implies the elevation of duodenum and the head of pancreas (Kocher maneuver) and access to the upper mesenteric vein and artery and its branches. For tumors of the left colon, mobilization of sigma and descending colon is necessary, total separation from the parietal peritoneum, urethra, testicular or ovarian blood vessels, as well as separation from the kidney fat tissue.

The apparent improved outcomes with complete mesocolic excision are yet to be confirmed with a formal Randomized Controlled Trial (RCT). Proposed explanations for the apparent improvements are that increasing lymph node yield permits stage migration, that increased lymph node yield removes a source of metastases, and that it has nothing to do with lymphatics but is due to the preservation of an intact peritoneum.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dakahlia
      • El Mansura, Dakahlia, Egypt, 35516
        • Recruiting
        • Oncology Center Mansoura University (OCMU), Egypt
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Osama Eldamshety
  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • National Cancer Institute "Fond. G. Pascale"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically proven adenocarcinoma (including mucinous and signet-ring cell) or adenosquamous carcinoma on endoscopic biopsy.
  • Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging [barium enema or computed tomography (CT)] without location of the lower border of the tumor at the rectum.
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
  • Body mass index ≤ 35.
  • Sufficient organ function including cardiovascular system and liver.
  • Written informed consent.

Exclusion Criteria:

  • Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
  • Infectious disease requiring treatment.
  • Body temperature ≥ 38 °C.
  • Pregnant women.
  • History of psychiatric disease.
  • Use of systemic steroids.
  • History of myocardial infarction or unstable angina pectoris within 6 months.
  • Severe pulmonary emphysema or pulmonary fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Comparison group

including the number of cases with complete data who underwent surgery using the conventional method.

Conventional surgery
Procedure: Conventional Surgery
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon
Active Comparator: Intervention group

including a convenient sample of about 20 patients which is expected to be recruited, for whom Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) will be done.

Complete mesocolic excision with central vascular ligation
Procedure: Complete mesocolic excision with central vascular ligation
excision of the whole mesocolon plus ligation of the supplying blood vessel centrally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph nodes harvest
Time Frame: Day of surgery
Number of retrieved lymph nodes
Day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncologic outcome
Time Frame: 2 years
Number of patients with local or distant recurrence after the surgery.
2 years
Operative outcome
Time Frame: Day of suregry
A composite outcome of the Operative time, blood loss, blood transfusion, intraoperative morbidities and mortality
Day of suregry
Postoperative outcome
Time Frame: 1 month
A composite outcome of the number of morbidities and mortalities in the postoperative setting
1 month
Survival outcome
Time Frame: 3 Years
Number of patients with 2 year free survival
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Mohamed Abdelkhalek, M.Sc, Oncology Center Mansoura University (OCMU), Egypt
  • Principal Investigator: Giovanni Romano, MD, National Cancer Institute "Fond. G. Pascale", Italy
  • Study Chair: Adel Denewer, MD, Oncology Center Mansoura University (OCMU), Egypt
  • Study Director: Tamer F Youssef, MD, Oncology Center Mansoura University (OCMU), Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 15, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Complete Mesocolic Excision

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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