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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Conventional Surgery
Complete mesocolic excision with central vascular ligation
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring colon cancer mesocolic excision central ligation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oncology Center Mansoura University (OCMU), EgyptRecruiting
  • National Cancer Institute "Fond. G. Pascale"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Comparison group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lymph nodes harvest
Number of retrieved lymph nodes

Secondary Outcome Measures

Oncologic outcome
Number of patients with local or distant recurrence after the surgery.
Operative outcome
A composite outcome of the Operative time, blood loss, blood transfusion, intraoperative morbidities and mortality
Postoperative outcome
A composite outcome of the number of morbidities and mortalities in the postoperative setting
Survival outcome
Number of patients with 2 year free survival

Full Information

First Posted
August 11, 2015
Last Updated
August 14, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02526836
Brief Title
Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer
Official Title
Complete Mesocolic Excision (CME) With Central Supplying Vessel Ligation (CVL) Compared With Conventional Surgery for Colon Cancer: a Double-blinded Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colon cancer mesocolic excision central ligation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison group
Arm Type
Other
Arm Description
including the number of cases with complete data who underwent surgery using the conventional method. Conventional surgery
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Intervention Description
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon
Intervention Type
Procedure
Intervention Name(s)
Complete mesocolic excision with central vascular ligation
Intervention Description
excision of the whole mesocolon plus ligation of the supplying blood vessel centrally
Primary Outcome Measure Information:
Title
Lymph nodes harvest
Description
Number of retrieved lymph nodes
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Oncologic outcome
Description
Number of patients with local or distant recurrence after the surgery.
Time Frame
2 years
Title
Operative outcome
Description
A composite outcome of the Operative time, blood loss, blood transfusion, intraoperative morbidities and mortality
Time Frame
Day of suregry
Title
Postoperative outcome
Description
A composite outcome of the number of morbidities and mortalities in the postoperative setting
Time Frame
1 month
Title
Survival outcome
Description
Number of patients with 2 year free survival
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdelkhalek, M.Sc
Phone
+201001850214
Email
mabdelkhalek@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Setit, MD
Email
asetit@mans.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelkhalek, M.Sc
Organizational Affiliation
Oncology Center Mansoura University (OCMU), Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giovanni Romano, MD
Organizational Affiliation
National Cancer Institute "Fond. G. Pascale", Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adel Denewer, MD
Organizational Affiliation
Oncology Center Mansoura University (OCMU), Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tamer F Youssef, MD
Organizational Affiliation
Oncology Center Mansoura University (OCMU), Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Oncology Center Mansoura University (OCMU), Egypt
City
El Mansura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelkhalek, M.Sc
Phone
+201001850214
Email
mabdelkhalek@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed Setit, MD
Email
asetit@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Osama Eldamshety
Facility Name
National Cancer Institute "Fond. G. Pascale"
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Romano, MD
Phone
+39 081 5903 311
Email
gromano53@katamail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes
Citations:
PubMed Identifier
19016817
Citation
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.
Results Reference
background
PubMed Identifier
25555421
Citation
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.
Results Reference
background

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

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