NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Not Applicable

Terminated

• Conditions: Esophageal Stricture; Anastomotic Stenosis; Dilation of Esophagus Due to Disease

• Registration Number: NCT04406428
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-28
• Study Start: 2020-09-14
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dilation free time	6 months	EBD-free time

Secondary Outcome Measures

Name	Time	Method
Cost-reduction	6 months
Cost-effectiveness	6 months
Endoscopic procedures	6 months	Number of endoscopic procedures for treatment of dysphagia
QoL	6 months	Quality of life

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands