Encapsulation-oriented vs. Timing-oriented Strategies for Necrotizing Pancreatitis

Launched by TOKYO UNIVERSITY · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for a procedure called endoscopic ultrasound (EUS)-guided drainage to treat a serious condition called necrotizing pancreatitis, where parts of the pancreas become damaged and form collections of dead tissue and fluid. Usually, doctors wait about four weeks after symptoms start before doing this drainage to let the damaged area become surrounded by a protective wall (called encapsulation). This study is comparing two approaches: one where doctors wait until at least 80% of the damaged area is surrounded by this wall before draining, and another where they drain at the usual time of four to five weeks, no matter how much encapsulation has formed. The goal is to see which method helps patients feel better faster, clears the damaged tissue more effectively, and causes fewer complications.

To join this study, patients need to be adults (18 years or older) recently diagnosed with necrotizing pancreatitis—within about four weeks of symptoms starting—and confirmed by specific imaging tests like a CT scan. People who have already had drainage done, have chronic pancreatitis, are pregnant, or have other health reasons that make endoscopic treatment unsafe won’t be able to participate. If accepted, participants will be randomly assigned to one of the two groups and closely monitored for up to six months to track their recovery, any side effects, and whether the fluid collections come back. This research aims to find the safest and most effective way to treat this condition, which could improve care for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with necrotizing pancreatitis according to the revised Atlanta classification, confirmed by contrast-enhanced CT (plain CT or MRI may be substituted if contrast-enhanced CT is not feasible).
• • Within 28 days of onset of acute pancreatitis.
• • Age ≥ 18 years at the time of consent, regardless of sex.
• • Provided written informed consent from the patient or a legally authorized representative after sufficient explanation.
• • Patients who are either hospitalized or being followed as outpatients at participating study institutions.
• Exclusion Criteria:
• • Unknown date of onset of acute pancreatitis.
• • Patients who have already undergone transluminal drainage with stent placement for necrotizing pancreatitis.
• • Diagnosis of chronic pancreatitis.
• • Patients for whom endoscopic treatment is deemed unsafe.
• • Pregnant women.
• • Patients deemed inappropriate for the study by the principal investigator or sub-investigator.