NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Esophageal Stricture Clinical Trial

— SAMURAI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406428
• Other study ID #: NL65652.091.18
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: September 14, 2025

Study information

• Verified date: September 2022
• Source: Radboud University Medical Center
• Contact: Lieke Koggel, Drs.
• Phone: +316-25678774
• Email: lieke.koggel[@]radboudumc.nl
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 99
• Est. completion date: September 14, 2025
• Est. primary completion date: September 14, 2025
• 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.

Related Conditions & MeSH terms

• Anastomotic Stenosis
• Constriction, Pathologic
• Dilation of Esophagus Due to Disease
• Esophageal Stenosis
• Esophageal Stricture

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