Enteral Stents for Colonic Obstruction (ESCO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by European Association for Endoscopic Surgery
Sponsor:
Information provided by (Responsible Party):
Alberto Arezzo, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier:
NCT00591695
First received: December 29, 2007
Last updated: April 26, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to verify whether stent positioning for malignant obstruction of the colon and rectum followed by elective surgery allows reduction of postoperative complications and hospital stay without worsening of evolution of the neoplastic illness, compared to emergency surgery.

Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be postoperative mortality, length of hospital stay, need for analgesia.


Condition Intervention Phase
Malignant Colorectal Obstruction
Procedure: Stent bridge to surgery + elective surgery
Procedure: Emergency Surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomised European Multicentric Study, Comparing Enteral Stent Followed by Elective Surgery Versus Emergency Surgical Treatment in Malignant Colonic Obstruction

Resource links provided by NLM:


Further study details as provided by European Association for Endoscopic Surgery:

Primary Outcome Measures:
  • incidence of postoperative complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • success percentage of stent positioning in emergency [ Time Frame: at stent positioning ] [ Designated as safety issue: No ]
  • percentage of complications related to stent positioning [ Time Frame: at stent positioning ] [ Designated as safety issue: Yes ]
  • length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • quality of life and survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • cost differences [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • oncological results (local and distant recurrence rate) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: January 2008
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
positioning in emergency of a prosthetic metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour
Procedure: Stent bridge to surgery + elective surgery
positioning in emergency of a metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour
Other Name: Colorectal stenting with metallic self-expanding stent + elective surgery
Active Comparator: B
emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
Procedure: Emergency Surgery
Emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
Other Names:
  • Resection followed by enterostomy (Hartmann procedure)
  • 'On table' washing and primary anastomoses
  • Subtotal colectomy

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • malignant colonic obstruction localized between splenic flexure and 15 cm from anal margin diagnosed by CTScan.
  • Possibility of endoscopy and stent location during next 24 h after diagnostic.
  • Clinical occlusion to gas and faeces.
  • Informed consent obtained from the patient or from a relative in case of inability.

Exclusion Criteria:

  • Bowel perforation diagnosed by clinical exploration and complementary studies.
  • Associated pathologies contraindicating general anaesthesia and/or haemodynamic instability.
  • Impossibility to gain a valid informed consent or refusal from the patient.
  • Patients with multiple liver metastases diagnosed by CTScan at the moment of diagnostic and not considered operable with curative intention following the standards of every center.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591695

Contacts
Contact: Carmen Balagué +34935565671 cbalague@santpau.es
Contact: Alberto Arezzo, MD +393358378243 alberto.arezzo@unito.it

Locations
Italy
Department of Surgery, Minimally Invasive Surgery Center, University of Torino Recruiting
Torino, Italy, 10126
Contact: Mario Morino, Professor of Surgery    +390116335670    mario.morino@unito.it   
Contact: Alberto Arezzo, MD    +393358378243    alberto.arezzo@unito.it   
Principal Investigator: Mario Morino, Professor of Surgery         
Sub-Investigator: Alberto Arezzo, MD         
Sub-Investigator: Mauro Toppino, Associate Professor         
Sub-Investigator: Corrado Garrone, Aggregate Professor         
Sub-Investigator: Fabrizio Rebecchi, Aggregate Professor         
Sub-Investigator: Giuseppe Giraudo, MD         
Sub-Investigator: Giuseppe Benedetto, MD         
Sub-Investigator: Giuseppe Mingrone, MD         
Sub-Investigator: Claudio Miglietta, MD         
Sub-Investigator: Massimiliano Mistrangelo, MD         
Sub-Investigator: Gisella Bonnet, MD         
Sub-Investigator: Mario Caldart, MD         
Sub-Investigator: Aldo Garbarini, MD         
Sub-Investigator: Ugo Serenthà, MD         
Sub-Investigator: Giancarlo Rozio, MD         
Sub-Investigator: Marco Rossetti, MD         
Sub-Investigator: Giorgio Olivero, Associate Professor         
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Eduardo M Targarona, Professor of Surgery    +34935565671    etargarona@santpau.es   
Contact: Carmen Balagué, MD    +34935565671    cbalague@santpau.es   
Principal Investigator: Eduardo M Targarona, Professor of Surgery         
Sub-Investigator: Carmen Balagué, MD         
Sub-Investigator: Sergio Sainz, MD         
Sub-Investigator: Ferran Caballero, MD         
Sub-Investigator: Carmen Martinez, MD         
Sub-Investigator: Pilar Hernandez, MD         
Sub-Investigator: Jorgi Garriga, MD         
Sub-Investigator: Manuel Trias, MD         
Sponsors and Collaborators
European Association for Endoscopic Surgery
Investigators
Principal Investigator: Mario Morino, Professor of Surgery University of TORINO - European Association for Endoscopic Surgery
Principal Investigator: Eduardo M Targarona, Professor of Surgery Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

Additional Information:
No publications provided

Responsible Party: Alberto Arezzo, Assistant Professor of Surgery, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier: NCT00591695     History of Changes
Other Study ID Numbers: EAES-1
Study First Received: December 29, 2007
Last Updated: April 26, 2014
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by European Association for Endoscopic Surgery:
Malignant Colorectal Obstruction
Stent Bridge to Surgery

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014