TerminatedNot Applicable

NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Stopped: Inclusions

Netherlands15 participantsStarted 2020-09-14

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Dilation free time

Timeframe: 6 months

Trial details

NCT IDNCT04406428

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-20