Status:
TERMINATED
NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
The Netherlands Cancer Institute
Conditions:
Esophageal Stricture
Anastomotic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy will result in an increased dysphagia-free period, a reduction of endoscopic procedures and dysphagia-related ...
Eligibility Criteria
Inclusion
- Recurrent intra- or extrathoracic benign esophagogastric anastomotic stricture after esophagectomy. The definition of a stricture is based on the Ogilvie Dysphagia score (severity of dysphagia), i.e. Ogilvie score ≥2 (= ability to swallow semi-solid food or worse (Appendix table 1)).
- No patency for a standard endoscope (diameter \< 10 mm)
- The recurrent stricture has been previously treated with at least 1 to a maximum of 5 EBD sessions that reached an esophageal diameter of ≥16 mm.
- The stricture should be suitable for endoscopic incision (stricture length ≤10 mm).
Exclusion
- Benign esophageal stricture other than an esophagogastric anastomotic stricture.
- Strictures with a morphology unsuitable for NKI, such as long (\>1 cm), irregulair or tortuous strictures.
- Previous endoscopic treatment of the esophageal stricture with steroid injection, incision therapy or stent placement within the past 3 months.
- Previous stent placement post-esophagectomy for anastomotic leakage.
- (Suspicion of) locally 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 that cannot pre-procedural be corrected.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04406428
Start Date
September 14 2020
End Date
February 20 2024
Last Update
June 17 2024
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB