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

Completed

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

• Registration Number: NL-OMON23356
• Lead Sponsor: Address of correspondenceM.L. Hordijk, MDDepartment of Gastroenterology and HepatologyErasmus Medical Center Rotterdam University HospitalP.O. Box 20403000 CA RotterdamTel: + 31 010 4635946Email: m.hordijk@erasmusmc.nl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 62

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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. <br /><br>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. <br>

Secondary Outcome Measures

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