Clinical trial NCT04406428: NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures
Official title: Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Stricture
Anastomotic Stenosis
Dilation of Esophagus Due to Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: The Netherlands Cancer Institute
name: Leiden University Medical Center
name: UMC Utrecht
First posted: 2020-05-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 (= 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.

Primary outcomes:
measure: Dilation free time
timeFrame: 6 months
Secondary outcomes:
measure: Endoscopic procedures
timeFrame: 6 months
measure: QoL
timeFrame: 6 months
measure: Cost-reduction
timeFrame: 6 months
measure: Cost-effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: