Benign esophageal strictures
Conditions
Interventions
Intensive endoscopic therapy (=investigational treatment):
a) Endoscopic in- and excision of the stenotic fibrotic ring using a needle knife catheter.
b) Followed by injection of 0.5 ml aliquots Ken
Sponsors
Academic Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Untreated benign esophagogastric anastomotic stricture after esophagectomy. - The stricture should be suitable for endoscopic incision: a) Diagnosed at least 6 weeks after esophagectomy, and b) Stricture length ≤ 1 cm. - Dysphagia score ≥ 2. - Age > 18 years. - Written informed consent for study participation.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysphagia-free period | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of endoscopic dilations, technical success, procedure-related complications, dysphagia scores and therapy satisfaction score. | — |
Contacts
Public ContactE.E. Halsema, van
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Outcome results
None listed