Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial
- Conditions
- benign esophageal anastomotic stricturepostsurgical esophageal stricture1001800810017998
- Registration Number
- NL-OMON42848
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• Untreated benign esophagogastric anastomotic stricture after esophagectomy.
• The stricture should be suitable for endoscopic incision:
- Diagnosed at least 6 weeks after esophagectomy, and
- Stricture length <= 1 cm.
• Dysphagia score >= 2 = ability to swallow semi-solid food or worse.
• Age > 18 years.
• Written informed consent for study participation.
• Benign esophageal stricture other than an esophagogastric anastomotic stricture.
• Strictures with a morphology unsuitable for needle-knife incision, such as long (> 1 cm), irregulair or tortuous strictures.
• Previous endoscopic treatment of the esophageal stricture, such as bougie/balloon dilation, steroid injection, incision therapy or stent placement.
• Previous stent placement post-esophagectomy for anastomotic leakage.
• (Suspicion of) recurrent or metastasized esophageal cancer.
• Persisting postoperative esophageal fistula.
• Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.
• Known clotting disorder.
• Patients unable to provide written consent for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dysphagia-free period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of endoscopic dilations, technical success, procedure-related<br /><br>complications, dysphagia scores and therapy satisfaction score.</p><br>