Esophageal Stricture Clinical Trial
— SAMURAIOfficial title:
Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial
Verified date | June 2024 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | February 20, 2024 |
Est. primary completion date | February 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Erasmus Medical Center, Leiden University Medical Center, The Netherlands Cancer Institute, UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dilation free time | EBD-free time | 6 months | |
Secondary | Endoscopic procedures | Number of endoscopic procedures for treatment of dysphagia | 6 months | |
Secondary | QoL | Quality of life | 6 months | |
Secondary | Cost-reduction | 6 months | ||
Secondary | Cost-effectiveness | 6 months |
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