NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Study Overview
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Brief Summary
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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 quality of life, and lower costs, when compared with the standard endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures. Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI) followed by EBD compared to standard EBD in patients with recurrent esophagogastric anastomotic strictures. Study design: This multicenter study is an randomized controlled trial in which NKI followed by EBD will be compared with standard EBD. Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous dilations) due to an anastomotic esophagogastric stricture that requires treatment with repeated endoscopic bougie dilations. Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to 18 mm esophageal diameter. Main study parameters/endpoints: The primary outcome of this study will be EBD-free time during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and cost-effectiveness.

Official Title
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Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial

Conditions
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Esophageal Stricture, Anastomotic Stenosis, Dilation of Esophagus Due to Disease

Intervention / Treatment
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* Procedure: NKI followed by EBD


Participation Criteria
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Eligibility Criteria
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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 (= 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NKI followed by EBD<br> | Procedure: NKI followed by EBD<br>* Needle-knife incision therapy followed by endoscopic bougie dilation<br>|
| No Intervention: Standard EBD<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dilation free time | EBD-free time | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic procedures | Number of endoscopic procedures for treatment of dysphagia | 6 months | 
| QoL | Quality of life | 6 months | 
| Cost-reduction |  | 6 months | 
| Cost-effectiveness |  | 6 months |