Endoscopic Treatment of Anastomotic Esophageal Stricture. A Randomised Study Comparing Initial Dilation by Electrocautery with Savary Bougies with Electrocautery.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR931
• Date of registration: 12/03/2007
• Primary sponsor: Erasmus Medical Center, Department of Hepatology and Gastroenterology
• Public title: Endoscopic Treatment of Anastomotic Esophageal Stricture. A Randomised Study Comparing Initial Dilation by Electrocautery with Savary Bougies with Electrocautery.
• Scientific title: Endoscopic Treatment of Anastomotic Esophageal Stricture. A Randomised Study Comparing Initial Dilation by Electrocautery with Savary Bougies with Electrocautery. - Endoscopic Treatment of Anastomotic Esophageal Stricture. A Randomised Study Comparing Initial Dilation by Electrocautery with Savary Bougies with Electrocautery.
• Date of first enrolment: 17/6/2004
• Target sample size: 62
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=931
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: M.L. Hordijk

• Name: M.L. Hordijk

Key inclusion & exclusion criteria

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 randomized to either treatment arm. After informed consent, patients will either undergo dilation with Savary bougies, or primary electocautery.
Exclusion criteria: 1. Esophageal dilation with bougies or electrocautery is rarely contraindicated.
Patients should however not be dilated if they recently suffered from acute esophageal perforation.

2. Dilation is relatively contraindicated in the presence of:

a. a bleeding diathesis,

b. severely compromised pulmonary function,

c. severe or unstable cardiac disease, or in

d. patients with large thoracic aortic aneurysms (47).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Anastomotic esophageal stricture, Electrocautery, Savary bougies, Randomised study, Dilatation

Intervention(s)

- 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 (Wilson Cook) of increasing diameter over the guidewire 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 visualization. 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 caliber 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.).

Primary Outcome(s)

This study aims to compare the efficacy of Savary dilation versus endoscopic electrocautery treatment for the treatment of fibrotic anastomotic strictures after esophageal resection. 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.
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.

The EORTC health related Quality of Life Questionnaires SF-36, C-30 (version 3) and OES 18 are used to structure a quality of life questionnaire especially focused on benign esophageal stenosis.

Secondary Outcome(s)

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

Secondary ID(s)

ISRCTN81239664

N/A

Source(s) of Monetary Support

Erasmus Medical Center