NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2024-02-20

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.

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Detailed Description

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Conditions

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Esophageal Stricture Anastomotic Stenosis Dilation of Esophagus Due to Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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NKI followed by EBD

Group Type EXPERIMENTAL

NKI followed by EBD

Intervention Type PROCEDURE

Needle-knife incision therapy followed by endoscopic bougie dilation

Standard EBD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NKI followed by EBD

Needle-knife incision therapy followed by endoscopic bougie dilation

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No