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Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

This study has been terminated.
(enrolling participants stopped)
Sponsor:
Collaborators:
University Hospital, Rouen
University Hospital, Toulouse
University Hospital, Grenoble
Rennes University Hospital
University Hospital, Lille
University Hospital, Angers
University Hospital, Bordeaux
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT00514332
First received: August 8, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

To evaluate wether colorectal stenting carry a significant clinical advantage


Condition Intervention
Colorectal Obstruction
Left Colonic Adenocarcinoma
 Procedure: stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • number of stoma in each group [ Time Frame: within the first 6 month(plus or minus 1 month) after surgery ]

Secondary Outcome Measures:
  • mortality in each group [ Time Frame: within the first 6 month (plus or minus 1 month) after surgery ]
  • complications [ Time Frame: within the first 6 month (plus or minus 1 month) after surgery ]
  • number of procedures [ Time Frame: within the first 6 month (plus or minus 1 month) after surgery ]
  • length of stay [ Time Frame: within the first 6 month (plus or minus 1 month) after surgery ]

Enrollment: 70
Study Start Date: December 2002
Study Completion Date: October 2006
Arms Assigned Interventions
Experimental: A
primary surgery group
 Procedure: stent
stent placement for colorectal cancer obstruction
Other Name: self-expending metallic stents

Detailed Description:

Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obstructive stenosis due to left colorectal cancer

Exclusion Criteria:

  • previous colorectal cancer
  • other colorectal location
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514332

Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Rouen
University Hospital, Toulouse
University Hospital, Grenoble
Rennes University Hospital
University Hospital, Lille
University Hospital, Angers
University Hospital, Bordeaux
Investigators
Principal Investigator: Bertrand L MILLAT, MD-PhD University Hospital, Montpellier
  More Information

No publications provided by University Hospital, Montpellier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00514332     History of Changes
Other Study ID Numbers: UF7683
Study First Received: August 8, 2007
Last Updated: August 8, 2007
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Montpellier:
colorectal stents
colonic obstruction
colonic adenocarcinoma
colorectal surgery

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Colonic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Colorectal Neoplasms
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013