NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures (SAMURAI)

Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Stricture; Anastomotic Stenosis; Dilation of Esophagus Due to Disease
• Intervention / Treatment: Procedure: NKI followed by EBD

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieke Koggel, Drs.; Phone Number: +316-25678774; Email: lieke.koggel@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Recruiting
      • Radboudumc
      • Contact: Lieke Koggel, Drs.; Phone Number: +316-25678774; Email: lieke.koggel@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NKI followed by EBD	Procedure: NKI followed by EBD; Needle-knife incision therapy followed by endoscopic bougie dilation
No Intervention: Standard EBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dilation free time	EBD-free time	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic procedures	Number of endoscopic procedures for treatment of dysphagia	6 months
QoL	Quality of life	6 months
Cost-reduction		6 months
Cost-effectiveness		6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: UMC Utrecht; Erasmus Medical Center; The Netherlands Cancer Institute; Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Anticipated): September 14, 2025
• Study Completion (Anticipated): September 14, 2025

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID Numbers: NL65652.091.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No