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Enteral Stents for Colonic Obstruction (ESCO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alberto Arezzo, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier:
NCT00591695
First received: December 29, 2007
Last updated: January 20, 2016
Last verified: January 2016
  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
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

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

Primary Outcome Measures:
  • incidence of postoperative complications [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • postoperative mortality [ Time Frame: 30 days ]
  • success percentage of stent positioning in emergency [ Time Frame: at stent positioning ]
  • percentage of complications related to stent positioning [ Time Frame: at stent positioning ]
  • length of hospital stay [ Time Frame: 3 months ]
  • quality of life and survival [ Time Frame: 3 years ]
  • cost differences [ Time Frame: 3 months ]
  • oncological results (local and distant recurrence rate) [ Time Frame: 3 years ]

Enrollment: 144
Study Start Date: January 2008
Estimated Study Completion Date: July 2018
Primary Completion Date: July 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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Locations
Italy
Department of Surgery, Minimally Invasive Surgery Center, University of Torino
Torino, Italy, 10126
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
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:
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: January 20, 2016

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

ClinicalTrials.gov processed this record on February 20, 2017