Enteral Stents for Colonic Obstruction (ESCO)

July 24, 2018 updated by: Alberto Arezzo, European Association for Endoscopic Surgery

Prospective, Randomised European Multicentric Study, Comparing Enteral Stent Followed by Elective Surgery Versus Emergency Surgical Treatment in Malignant Colonic Obstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction & background In emergency surgery, although surgical and resuscitation techniques were improved, the postoperative complications and mortality rates are still high and however higher than for those patients that underwent to elective surgery (1-3). Using a Metallic prosthesis stent in an obstructed colon allows to transform an emergency surgical case into an elective surgery case. This allows to restore the bowel transit and to operate in elective condition reducing morbidity, mortality and the need of an enterostomy (4-10).

Although there are recent outcomes on literature about use of a decompressive stent before surgery in obstructed patients from malignant colic tumours, there are no prospective and randomised studies were stent positioning followed by elective surgery is compared with emergency surgery.

Study design Prospective, randomized multicentric clinical trial where samples are patients with emergency room diagnosis of obstructing colonic neoplasm.

Once informed and obtained consent, patients will be included in the study and randomized in one of the two branches of the study: A.- enteral stent positioning followed by second time resection in the same hospital stay. B.- emergency surgical treatment consisting in Hartmann operation or resection with same time anastomosis. Results from transit reconstruction in patients underwent Hartmann operation will be considered in the study.

Short term clinical evolution control in order to determine postoperative morbility and mortality, hospital stay.

Follow-up will be performed to evaluate survival rate and disease free survival.

Endpoints To evaluate and compare the results obtained using enteral stent followed by elective surgery versus common emergency surgical techniques.

Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be: postoperative mortality, length of hospital stay, need for analgesia. Long term follow up with specific instrumental controls (CT scan, US, colonoscopy or RX clysma) to identify disease recurrences or metastases as cost analysis and patient's quality of life will also be evaluated.

Statistics & randomization In prospective series analysed in different centres, the incidence of postoperative complications in patients underwent to emergency colonic surgery was 35%. The positioning of the stent associated to second time surgical elective treatment is characterized by 15% of morbidity (stent: 5%, surgery: 10%). The number of patients needed to carry on the study making statistically significant this difference (35% vs 15%) with an error alpha = 0.05 and beta = 0.2 and estimating a loss of 5% of the samples, is 72 patients in each group.

Randomization will be stratified for local extension of tumour (T4 vs others) and for presence or not of liver metastases.

Main selection criteria Inclusion of patients with malignant colonic obstruction localized between promontorium and splenic flexure and diagnosed by CTScan. Those patients with peritonitis, pneumoperitoneum, synchronic colonic tumour, pregnant or haemodynamic instability will be excluded.

Follow-up Same follow-up as patients diagnosed and treated for Colon Cancer following the protocol of each center, never less than 3 years. During follow-up required complementary studies will be performed in each case in order to evaluate local recurrence or distant metastases. Also quality of life and costs will be evaluated.

Expected results: reduction of postoperative complications and hospital stay in patients submitted to stent positioning without worsening of evolution of the neoplastic illness.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10126
        • Department of Surgery, Minimally Invasive Surgery Center, University of Torino
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of postoperative complications
Time Frame: 60 days
60 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 29, 2007

First Submitted That Met QC Criteria

December 29, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EAES-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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