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NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

NCT04406428 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-17

No results posted yet for this study

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.

Conditions

  • Esophageal Stricture
  • Anastomotic Stenosis
  • Dilation of Esophagus Due to Disease

Interventions

PROCEDURE

NKI followed by EBD

Needle-knife incision therapy followed by endoscopic bougie dilation

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2024-02-20
Completion
2024-02-20

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406428 on ClinicalTrials.gov