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Status unknownNCT02526836Updated Aug 16, 2018

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

A Phase 2/3 interventional study of Conventional Surgery and Complete mesocolic excision with central vascular ligation in Colon Cancer, sponsored by Mansoura University. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-16.

Sponsored by Mansoura University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colon Cancer

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Keywords

  • colon cancer mesocolic excision central ligation
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In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 40 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Comparison group

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

    Procedure: Conventional Surgery

  • 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

Interventions

  • ProcedureConventional Surgery

    removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon

  • ProcedureComplete mesocolic excision with central vascular ligation

    excision of the whole mesocolon plus ligation of the supplying blood vessel centrally

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What researchers measure

Primary outcomes

  1. Lymph nodes harvest

    Number of retrieved lymph nodes

    Time frame: Day of surgery

Secondary outcomes

  1. Oncologic outcome

    Number of patients with local or distant recurrence after the surgery.

    Time frame: 2 years

  2. Operative outcome

    A composite outcome of the Operative time, blood loss, blood transfusion, intraoperative morbidities and mortality

    Time frame: Day of suregry

  3. Postoperative outcome

    A composite outcome of the number of morbidities and mortalities in the postoperative setting

    Time frame: 1 month

  4. Survival outcome

    Number of patients with 2 year free survival

    Time frame: 3 Years

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Study locations

2 of 2 sites recruiting
  • Oncology Center Mansoura University (OCMU), Egypt
    El Mansura, Dakahlia 35516, Egypt
    Recruiting
  • National Cancer Institute "Fond. G. Pascale"
    Naples, 80131, Italy
    Recruiting
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References and documents

Publications

  • 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. PubMed 19016817 ↗
  • 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. PubMed 25555421 ↗

Individual participant data

Plan to share: Yes — Yes

Supporting information: Study protocol

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02526836
Lead sponsor
Mansoura University
Responsible party
Mohamed Abdelkhalek (Assistant Lecturer of Surgical Oncology, Mansoura University) — Principal investigator
First posted
Aug 18, 2015
Start date
Sep 2014
Primary completion
Sep 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Aug 16, 2018

Study contacts

Mohamed Abdelkhalek, M.Sc
Contact
mabdelkhalek@mans.edu.eg
+201001850214
Ahmed Setit, MD
Contact
asetit@mans.edu.eg
Mohamed Abdelkhalek, M.Sc
principal investigator · Oncology Center Mansoura University (OCMU), Egypt
Giovanni Romano, MD
principal investigator · National Cancer Institute "Fond. G. Pascale", Italy
Adel Denewer, MD
study chair · Oncology Center Mansoura University (OCMU), Egypt
Tamer F Youssef, MD
study director · Oncology Center Mansoura University (OCMU), Egypt

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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