Back to resultsNKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures (SAMURAI)
Primary Purpose
Esophageal Stricture, Anastomotic Stenosis, Dilation of Esophagus Due to Disease
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
NKI followed by EBD
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Stricture
Eligibility Criteria
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.
Sites / Locations
- RadboudumcRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NKI followed by EBD
Standard EBD
Arm Description
Outcomes
Primary Outcome Measures
Dilation free time
EBD-free time
Secondary Outcome Measures
Endoscopic procedures
Number of endoscopic procedures for treatment of dysphagia
QoL
Quality of life
Cost-reduction
Cost-effectiveness
Full Information
NCT ID
NCT04406428
First Posted
May 25, 2020
Last Updated
January 10, 2023
Sponsor
Radboud University Medical Center
Collaborators
Erasmus Medical Center, The Netherlands Cancer Institute, Leiden University Medical Center, UMC Utrecht
1. Study Identification
Unique Protocol Identification Number
NCT04406428
Brief Title
NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures
Acronym
SAMURAI
Official Title
Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
September 14, 2025 (Anticipated)
Study Completion Date
September 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Erasmus Medical Center, The Netherlands Cancer Institute, Leiden University Medical Center, UMC Utrecht
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stricture, Anastomotic Stenosis, Dilation of Esophagus Due to Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NKI followed by EBD
Arm Type
Experimental
Arm Title
Standard EBD
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
NKI followed by EBD
Intervention Description
Needle-knife incision therapy followed by endoscopic bougie dilation
Primary Outcome Measure Information:
Title
Dilation free time
Description
EBD-free time
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Endoscopic procedures
Description
Number of endoscopic procedures for treatment of dysphagia
Time Frame
6 months
Title
QoL
Description
Quality of life
Time Frame
6 months
Title
Cost-reduction
Time Frame
6 months
Title
Cost-effectiveness
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lieke Koggel, Drs.
Phone
+316-25678774
Email
lieke.koggel@radboudumc.nl
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieke Koggel, Drs.
Phone
+316-25678774
Email
lieke.koggel@radboudumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures
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