NL-OMON42848
Completed
Phase 3
Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial - INCA trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- benign esophageal anastomotic stricture
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 15
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Not specified
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