Esophageal StrictureSAMURAINCT04406428
NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures
A study testing NKI followed by EBD in people with Esophageal Stricture and Anastomotic Stenosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Stricture, Anastomotic Stenosis, Dilation of Esophagus Due to Disease
- What is being tested?
- NKI followed by EBD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Sep 2020to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- NKI followed by EBD
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKI followed by EBDProcedure or surgery
Needle-knife incision therapy followed by endoscopic bougie dilation
| Study group | Role | What they receive |
|---|---|---|
| NKI followed by EBD | Experimental | Not described Receives: Procedure: NKI followed by EBD |
| Standard EBD | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dilation free time
EBD-free time
Measured: 6 months
Secondary outcomes (4)
Endoscopic procedures
Number of endoscopic procedures for treatment of dysphagia
Measured: 6 months
QoL
Quality of life
Measured: 6 months
Cost-reduction
Measured: 6 months
Cost-effectiveness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start14 Sep 2020
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Why it stopped: Inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, The Netherlands Cancer Institute, Leiden University Medical Center, UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406428
- Sponsor's protocol ID
- NL65652.091.18
- Acronym
- SAMURAI
- Status last verified
- Jun 2024
- First submitted
- 25 May 2020
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04406428
- Acronym / sponsor ID
- SAMURAI / NL65652.091.18
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusions
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, The Netherlands Cancer Institute, Leiden University Medical Center, UMC Utrecht
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NKI followed by EBD | Experimental | Procedure: NKI followed by EBD |
| Standard EBD | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKI followed by EBDNeedle-knife incision therapy followed by endoscopic bougie dilation | Procedure or surgery | NKI followed by EBD |
Primary outcome
Dilation free time
Time frame: 6 months
EBD-free time
4 secondary outcomes
Endoscopic procedures
Time frame: 6 months
QoL
Time frame: 6 months
Cost-reduction
Time frame: 6 months
Cost-effectiveness
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Esophageal Stricture
Enrolling by invitation
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
Esophageal Stenosis Acquired
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
RecruitingObservational study
Abbott Cephea Mitral Valve Disease Registry
Mitral Regurgitation, Mitral Stenosis
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NKI followed by EBD in people with Esophageal Stricture and Anastomotic Stenosis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dilation free time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.