Endoscopic treatment of anastomotic oesophageal stricture: a randomised study comparing initial dilation by electrocautery with Savary bougies with electrocautery
| ISRCTN | ISRCTN81239664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81239664 |
| Secondary identifying numbers | NTR931 |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 20/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M L Hordijk
Scientific
Scientific
Department of Gastroenterology and Hepatology
Erasmus Medical Centre Rotterdam
University Hospital
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | + 31 (0)10 463 5946 |
|---|---|
| m.hordijk@erasmusmc.nl |
Study information
| Study design | Randomised controlled parallel group double blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Approval received from the METC Erasmus MC on the 12th May 2004 (ref: MEC 238.671/2004/8). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 17/06/2004 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 62 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 17/06/2004 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Gastroenterology and Hepatology
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Hepatology and Gastroenterology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No |
