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Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial

Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial - Endoscopic treatment for walled-off necrosis using plastic stents vs. biflanged metal stent, prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015322
Enrollment
40
Registered
2014-10-02
Start date
2014-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Walled-off necrosis

Interventions

In the patients of PS group, conventional EUS guided transmural drainage using plastic stents is performed. In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated bifla

Sponsors

Tokyo Medical University Hospital Department of Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with symptomatic sterile or infected walled-off necrosis, which can be punctured safely from stomach or duodenum under endoscopic ultrasound. 2)Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.

Exclusion criteria

Exclusion criteria: 1)Cases with sever complication in other organs except original disease 2)Cases having impossibility of cessation of anticoagulant 3)Cases with pregnancy or suspect of pregnancy 4)Cases with malignant cancer not having more than a half year prognosis 5)Cases that the size of lesion is less than 3 cm 6)Cases having difficulty in endoscopic approach 7)Cases having difficulty in visualization of lesion on EUS 8)Cases judged by principal investigator to be inadequate as subjects

Design outcomes

Primary

MeasureTime frame
technical success rate, clinical success rate adverse event rate, mortality rate

Countries

Japan

Contacts

Public ContactShuntaro Mukai

Tokyo Medical University Department of Gastroenterology and Hepatology

maezora1031@yahoo.co.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026