eedle-knife incision therapy compared to usual care of recurrent gastroesophageal anastomotic strictures: a multicenter randomized controlled trial (SAMURAI-study)

Recruiting

• Conditions: benign esophagogastric anastomotic stricture; esophageal narrowing; 10018008

• Registration Number: NL-OMON55878
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 46

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)).
- 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).
- Age *18 years.
- Written informed consent for study participation.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study will be the EBD-free period during follow-up<br /><br>after reaching an esophageal diameter of 18 mm.</p><br>