benign esophagogastric anastomotic stricture esophageal narrowing
Conditions
Interventions
The intervention to be investigated is this study is the addition of NKI
therapy to EBD in patients with a recurrent esophagogastric anastomotic
stricture.
Needle-knife incision (and excision): Thi
ERBE
Electromedizin GmbH, Tubingen, Germany) with software-controlled fractionated
cuts. The effective cutting power will be maximized at 120 W for 50 ms. The
maximum coagulation power during the f
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 (
Exclusion criteria
Exclusion criteria: * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study will be the EBD-free period during follow-up after reaching an esophageal diameter of 18 mm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: * Total number of endoscopic procedures from initial dilation to 18 mm to 6 months of follow-up. The 6-month follow-up will start from the moment 18 mm esophageal diameter is reached. * The number of dysphagia-free patients without the need for repeat EBDs after 6-month follow-up. * Procedure-related complications, such as: severe cervical or thoracic pain requiring analgesics, perforation, fistula formation, clinically relevant bleeding requiring an intervention, a blood transfusion or (prolongation of) hospitalization. * Dysphagia score according to the Ogilvie (Appendix Table 1) 17 and Dakkak and Bennett scores (Appendix Table 2) 16. * Retrosternal pain, measured with a Visual Analog Scale (VAS). * Number of days from the first endoscopic procedure to the ability to tolerate a normal diet. Patients will keep a diary with daily dysphagia scores from baseline to day 14 after completion of the dilations (up to 18 mm) and thereafter weekly up to 6 months. * Health-related and disease-specific quality of life (EQ-5D18, EORTC QLQ-C30, EORTC OES-1819). * Costs and cost-effectiveness. * Technical success of: o NKI therapy followed by EBD, is defined as the ability to successfully reach a luminal diameter of 18 mm in one or two endoscopic procedures. Standard repeated EBD, is defined as the ability to successfully reach a luminal diameter of 18 mm with repeated EBD. | — |
Countries
Netherlands
Outcome results
None listed