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

NCT ID: NCT00514332

Last Updated: 2007-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-10-31

Brief Summary

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To evaluate wether colorectal stenting carry a significant clinical advantage

Detailed Description

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

Conditions

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Colorectal Obstruction Left Colonic Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

primary surgery group

Group Type EXPERIMENTAL

stent

Intervention Type PROCEDURE

stent placement for colorectal cancer obstruction

Interventions

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stent

stent placement for colorectal cancer obstruction

Intervention Type PROCEDURE

Other Intervention Names

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self-expending metallic stents

Eligibility Criteria

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Inclusion Criteria

* obstructive stenosis due to left colorectal cancer

Exclusion Criteria

* previous colorectal cancer
* other colorectal location
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Principal Investigators

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Bertrand L MILLAT, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

References

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Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.

Reference Type DERIVED
PMID: 21170659 (View on PubMed)

Other Identifiers

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UF7683

Identifier Type: -

Identifier Source: org_study_id