Anastomotic Stenosis, Dilation of Esophagus Due to Disease, Esophageal Stricture
Conditions
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 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.
Interventions
PROCEDURENKI followed by EBD
Needle-knife incision therapy followed by endoscopic bougie dilation
Sponsors
Erasmus Medical Center
The Netherlands Cancer Institute
Leiden University Medical Center
UMC Utrecht
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dilation free time | 6 months | EBD-free time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic procedures | 6 months | Number of endoscopic procedures for treatment of dysphagia |
| QoL | 6 months | Quality of life |
| Cost-reduction | 6 months | — |
| Cost-effectiveness | 6 months | — |
Countries
Netherlands
Outcome results
None listed