NCT04871399

Brief Summary

An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
recruiting

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 Progress90%
Jul 2020Jan 2027

Study Start

First participant enrolled

July 13, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 14, 2022

Status Verified

September 1, 2022

Enrollment Period

6.5 years

First QC Date

April 23, 2021

Last Update Submit

November 11, 2022

Conditions

Colon Cancer

Keywords

colon cancerRight colon cancerComplete mesocolic excisionCMERight HemicolectomyRight Colectomy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival at 3 years

    The length of time after surgery without any signs or symptoms of local or distant recurrence.

    3 Years.

Secondary Outcomes (12)

  • Safety-Operative time.

    Intraoperative

  • Safety-Intraoperative blood loss.

    Intraoperative

  • Safety-Intraoperative blood transfusion.

    Intraoperative

  • Safety- Intraoperative Complications.

    Intraoperative

  • Early postoperative complications.

    30 postoperative days.

  • +7 more secondary outcomes

Study Arms (2)

Conventional Right hemicolectomy (Non-CME)

ACTIVE COMPARATOR

Patients will undergo conventional non-CME procedure.

Procedure: Conventional Right hemicolectomy (Non-CME)

Right hemicolectomy with CME+CVL

EXPERIMENTAL

Patients will undergo Right hemicolectomy CME+CVL procedure.

Procedure: Right hemicolectomy with CME+CVL

Interventions

Conventional Right hemicolectomy (Non-CME)PROCEDURE

Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted.

Conventional Right hemicolectomy (Non-CME)
Right hemicolectomy with CME+CVLPROCEDURE

Separation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly: * The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery * The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as well as The Right Gastroepiploic Vessels at their origin from the gastrocolic trunk of Henle (GCTH) and the gastroduodenal artery. The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance.

Right hemicolectomy with CME+CVL

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists(ASA) grade I-III.
  • Right colon cancer (\*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
  • Informed consent

You may not qualify if:

  • Age \> 85 years old.
  • T1, N0
  • T4b, any N
  • BMI \> 30.
  • Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
  • American Society of Anesthesiologists(ASA) grade IV.
  • History of cancer in recent 5 years.
  • Need for Emergency surgery.
  • Infectious disease requiring treatment.
  • Pregnancy.
  • Use of systemic steroids.
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ospedale della Misericordia

Grosseto, Arezzo, 52100, Italy

NOT YET RECRUITING

Ospedale Città di Sesto San Giovanni

Sesto San Giovanni, Milano, 20099, Italy

NOT YET RECRUITING

S. Andrea Hospital

La Spezia, Spezia, 19121, Italy

NOT YET RECRUITING

Candiolo Cancer Institute - IRCCS

Candiolo, Torino, 10060, Italy

NOT YET RECRUITING

Ospedale E. Agnelli Pinerolo

Pinerolo, Torino, 10064, Italy

NOT YET RECRUITING

Maggiore Bellaria Hospital, Bologna

Bologna, 40124, Italy

NOT YET RECRUITING

Università degli Studi di Ferrara

Ferrara, 44121, Italy

NOT YET RECRUITING

Ospedale Policlinico San Martino

Genova, 16132, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Messina, 98124, Italy

NOT YET RECRUITING

European Institute of Oncology

Milan, 20141, Italy

NOT YET RECRUITING

Federico II University

Napoli, 80138, Italy

NOT YET RECRUITING

University of Rome Tor Vergata

Rome, 00133, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

NOT YET RECRUITING

University of Turin (AOU.San Luigi Gonzaga)

Torino, 10043, Italy

RECRUITING

Related Publications (9)

  • Bertelsen CA. Complete mesocolic excision an assessment of feasibility and outcome. Dan Med J. 2017 Feb;64(2):B5334.

    PMID: 28157065BACKGROUND

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Benz S, Tannapfel A, Tam Y, Grunenwald A, Vollmer S, Stricker I. Proposal of a new classification system for complete mesocolic excison in right-sided colon cancer. Tech Coloproctol. 2019 Mar;23(3):251-257. doi: 10.1007/s10151-019-01949-4. Epub 2019 Mar 5.

    PMID: 30838463BACKGROUND

  • Johnson PM, Porter GA, Ricciardi R, Baxter NN. Increasing negative lymph node count is independently associated with improved long-term survival in stage IIIB and IIIC colon cancer. J Clin Oncol. 2006 Aug 1;24(22):3570-5. doi: 10.1200/JCO.2006.06.8866.

    PMID: 16877723BACKGROUND

  • Galizia G, Lieto E, De Vita F, Ferraraccio F, Zamboli A, Mabilia A, Auricchio A, Castellano P, Napolitano V, Orditura M. Is complete mesocolic excision with central vascular ligation safe and effective in the surgical treatment of right-sided colon cancers? A prospective study. Int J Colorectal Dis. 2014 Jan;29(1):89-97. doi: 10.1007/s00384-013-1766-x. Epub 2013 Aug 28.

    PMID: 23982425BACKGROUND

  • 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

  • Bertelsen CA, Bols B, Ingeholm P, Jansen JE, Neuenschwander AU, Vilandt J. Can the quality of colonic surgery be improved by standardization of surgical technique with complete mesocolic excision? Colorectal Dis. 2011 Oct;13(10):1123-9. doi: 10.1111/j.1463-1318.2010.02474.x.

    PMID: 20969719BACKGROUND

  • Kim NK, Kim YW, Han YD, Cho MS, Hur H, Min BS, Lee KY. Complete mesocolic excision and central vascular ligation for colon cancer: Principle, anatomy, surgical technique, and outcomes. Surg Oncol. 2016 Sep;25(3):252-62. doi: 10.1016/j.suronc.2016.05.009. Epub 2016 May 20.

    PMID: 27566031BACKGROUND

  • Degiuli M, Aguilar AHR, Solej M, Azzolina D, Marchiori G, Corcione F, Bracale U, Peltrini R, Di Nuzzo MM, Baldazzi G, Cassini D, Sica GS, Pirozzi B, Muratore A, Calabro M, Jovine E, Lombardi R, Anania G, Chiozza M, Petz W, Pizzini P, Persiani R, Biondi A, Reddavid R. A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial). Ann Surg Oncol. 2024 Mar;31(3):1671-1680. doi: 10.1245/s10434-023-14664-0. Epub 2023 Dec 12.

    PMID: 38087139DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Maurizio Degiuli, Professor

    University of Turin, Department of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Solej, MD

CONTACT

00393388624939mariosolej@gmail.com

Hogla Aridai Resendiz Aguilar, MD

CONTACT

00393512338942hogla.resendizagu@edu.unito.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 4, 2021

Study Start

July 13, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

November 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(14)