Condition category
Surgery
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
20/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M L Hordijk

ORCID ID

Contact details

Department of Gastroenterology and Hepatology
Erasmus Medical Centre Rotterdam
University Hospital
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+ 31 (0)10 463 5946
m.hordijk@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR931

Study information

Scientific title

Acronym

Study hypothesis

Anastomotic strictures are common after oesophageal resection. These strictures often need multiple dilation procedures with Savary bougies, and some even fail despite many dilations. Based on the literature and our pilot study of electrocautery therapy of refractory benign oesophageal stenosis, electrocautery treatment is safe, and may provide an excellent alternative for primary treatment of oesophageal strictures.

A prospective randomised controlled trial is needed to compare dilation therapy with Savary bouginage with electrocautery therapy for the primary treatment of these strictures.

Ethics approval

Approval received from the METC Erasmus MC on the 12th May 2004 (ref: MEC 238.671/2004/8).

Study design

Randomised controlled parallel group double blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Anastomotic oesophageal stricture

Intervention

Patients will either undergo dilation with Savary bougies, or primary electrocautery.

An upper gastrointestinal endoscopy will be performed. The postoperative stenosis will be inspected and the diameter of the stenosis will be estimated by using the diameter of the endoscope (9.5 mm). These stenoses are usually located at 17 to 20 cm from the incisors.

For endoscopic bougie dilation of the stricture, a guide wire will be placed in the stomach, followed by removal of the endoscope and passage of Savary Gilliard bougies of increasing diameter over the guide wire according to standard procedures to a diameter of minimal of 16 mm and maximal 19 mm.

For endoscopic dilation of the strictures with electrocautery, the tip of the endoscope is positioned just proximal from the stenosis, and a needle knife catheter (Wilson Cook, Boston Scientific) is introduced through the working channel. Radial incisions are made in the stenotic ring with the needle knife catheter under direct visualisation. The required length of the cut is gauged according to the length of the stricture assumed by the endoscopist in the light of the membranous nature and the calibre of the stricture. The depth of the incision (estimated using the length of the needle knife as a comparator) is not deeper than 4 mm. The length of the incision is dosed to completely remove the rim of the stenosis.

In case of recurrent stenosis, dilation therapy will be repeated with the same modality as was used at baseline. Recurrent stenosis is defined as no passage or only passage with pressure of the endoscope (diameter 9.5 mm).

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

This study aims to compare the efficacy of Savary dilation versus endoscopic electrocautery treatment for the treatment of fibrotic anastomotic strictures after oesophageal resection.
1. The efficacy of therapy will be evaluated by means of objective and subjective criteria, which will be determined both before treatment and during follow-up after treatment
2. The objective criteria are obtained by standard items at endoscopy and body weight. Endoscopic evaluation of the stricture will take place at baseline, and will be repeated in case of recurrent or persistent symptoms
3. The European Organisation for Research and Treatment of Cancer (EORTC) health related Quality of Life Questionnaires, Short Form 36-question health survey (SF-36), Quality of Life Questionnaire on Cancer (QLQ C-30) (version 3) and Quality of Life Oesophageal Questionnaire (QLQ OES-18) are used to structure a quality of life questionnaire especially focused on benign oesophageal stenosis

All outcomes will be measured at zero, one, three and six months.

Secondary outcome measures

Is there a difference in the interval of retreatment between electrocautery and Savary bougies, because of stenosis of the anastomosis of the oesophagus?

All outcomes will be measured at zero, one, three and six months.

Overall trial start date

17/06/2004

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Sixty-two unselected consecutive patients with dysphagia due to a benign anastomotic stricture after transhiatal oesophagectomy with gastric tube reconstruction and cervical anastomosis will be included and randomised to either treatment arm. After informed consent, patients will either undergo dilation with Savary bougies, or primary electocautery.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

62

Participant exclusion criteria

1. Oesophageal dilation with bougies or electrocautery is rarely contraindicated.
Patients should however not be dilated if they recently suffered from acute oesophageal perforation
2. Dilation is relatively contraindicated in the presence of:
2.1. a bleeding diathesis
2.2. severely compromised pulmonary function
2.3. severe or unstable cardiac disease, or in
2.4. patients with large thoracic aortic aneurysms

Recruitment start date

17/06/2004

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Gastroenterology and Hepatology
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Hepatology and Gastroenterology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19573869

Publication citations

  1. Results

    Hordijk ML, van Hooft JE, Hansen BE, Fockens P, Kuipers EJ, A randomized comparison of electrocautery incision with Savary bougienage for relief of anastomotic gastroesophageal strictures., Gastrointest. Endosc., 2009, 70, 5, 849-855, doi: 10.1016/j.gie.2009.02.023.

Additional files

Editorial Notes