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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23356

Enrollment

Registered

2007-03-12

Start date

2004-06-17

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

English:Anastomotic Esophageal Stricture, Randomised Study, Electrocautery, Savary Bougies, dilatation. Nederlands: stenose anastomose oesophagus, elektrocoagulatie, Savary Bougies, Gerandomiseerde studie

Interventions

- 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). T

Eligibility

Inclusion 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

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).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Contacts

Public ContactM.L. Hordijk

Department of Gastroenterology and Hepatology Erasmus Medical Center Rotterdam University Hospital P.O. Box 2040

m.hordijk@erasmusmc.nl+ 31 010 4635946

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)