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

JRCT ID: jRCTs031220696

Registered date:13/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: walled-off necrosis (WON)
• Date of first enrollment: 27/04/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Off-label use of hydrogen peroxide during endoscopic treatments for WON

Outcome(s)

• Primary Outcome: Incidence of moderate or severe adverse events during hospitalization

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takahara Naminatsu