NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Last updated: June 14, 2024
Sponsor: Radboud University Medical Center
Overall Status: Terminated

Phase

N/A

Condition

Esophageal Disorders

Achalasia

Treatment

NKI followed by EBD

Clinical Study ID

NCT04406428
NL65652.091.18
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recurrent intra- or extrathoracic benign esophagogastric anastomotic stricture afteresophagectomy. 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 foodor 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

Exclusion Criteria:

  • Benign esophageal stricture other than an esophagogastric anastomotic stricture.

  • Strictures with a morphology unsuitable for NKI, such as long (>1 cm), irregulair ortortuous 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 ofthe baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.

  • Known clotting disorder that cannot pre-procedural be corrected.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: NKI followed by EBD
Phase:
Study Start date:
September 14, 2020
Estimated Completion Date:
February 20, 2024

Connect with a study center

  • Radboudumc

    Nijmegen, Gelderland 6500 HB
    Netherlands

    Site Not Available

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