Safety and efficacy of hydrogen peroxide lavage during endoscopic treatments for walled-off necrosis

Phase 2

Recruiting

• Conditions: walled-off necrosis (WON); WO

• Registration Number: JPRN-jRCTs031220696
• Lead Sponsor: akai Yosuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

(1) Diagnose with WON by contrast CT based on revised Atlanta classification (diagnosis by non-contrast CT or MRI is allowed if participants have contraindications for contrast CT)
(2) Judged to be treated with drainage due to symptoms: fever, stomach pain, bloating or other bowel obstruction symptoms, jaundice
(3) Aged 18 years and above at the time of informed consent
(4) Male or female
(5) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation

Exclusion Criteria

(1) Not suitable for endoscopy, as follows:
1. Judge that endoscopic and percutaneous approaches to WON are impossible by clinical investigators
2. With hemorrhagic diathesis: platelet < 50,000 mm3 or PT-INR > 1.5
3. Taking antithrombotic therapy and unable to stop or change the antithrombotic drugs following Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment
4. Judged that it is impossible to perform endoscopic and percutaneous treatment safely by clinical investigators
(2) With a history of severe drug allergy including anaphylactic shock, or a history of
severe side effects
(3) With allergy to components of study drug
(4) Judged as ineligible by clinical investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of moderate or severe adverse events during hospitalization

Secondary Outcome Measures

Name	Time	Method
(1) Rate of clinical success (defined as lesion shrinkage and symptom improvement)<br>(2) Length of treatment<br>(3) Incidence of clinical events<br>(4) Length of hospitalization<br>(5) Incidence of adverse events