Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04406428
Other study ID # NL65652.091.18
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date February 20, 2024

Study information

Verified date June 2024
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
NKI followed by EBD
Needle-knife incision therapy followed by endoscopic bougie dilation

Locations

Country Name City State
Netherlands Radboudumc Nijmegen Gelderland

Sponsors (5)

Lead Sponsor Collaborator
Radboud University Medical Center Erasmus Medical Center, Leiden University Medical Center, The Netherlands Cancer Institute, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dilation free time EBD-free time 6 months
Secondary Endoscopic procedures Number of endoscopic procedures for treatment of dysphagia 6 months
Secondary QoL Quality of life 6 months
Secondary Cost-reduction 6 months
Secondary Cost-effectiveness 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04372784 - Cryoablation for Benign Gastrointestinal Anastomotic Strictures N/A
Recruiting NCT05581173 - Self-Assembling Matrix Forming Gel to Prevent Stricture Formation
Recruiting NCT00551824 - Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children N/A
Completed NCT04284826 - Mitomycin-C Injection Therapy in Refractory Esophageal Stricture N/A
Terminated NCT03898661 - Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures Early Phase 1
Withdrawn NCT04730076 - Balloon Dilation Methods for Benign Esophageal Stricture N/A
Active, not recruiting NCT03885310 - INGEST I Pilot Study N/A
Completed NCT02069847 - Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy Phase 2
Completed NCT03039608 - Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm N/A
Terminated NCT02354716 - EndoFLIP Use in Upper GI Tract Stenosis
Recruiting NCT05561114 - Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus Phase 3
Not yet recruiting NCT04524897 - The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children Phase 4
Not yet recruiting NCT04221867 - Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT) N/A