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The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis

The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis - The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011516
Enrollment
400
Registered
2013-08-19
Start date
2012-10-01
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

post-ERCP pancreatitis

Interventions

mixed amino acid medication regular diet

Sponsors

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: "Patient-related risk factors" 1) age younger than 60 years old, 2) female sex, 3) suspected bilialy sphincter of Oddi dysfunction (SOD), 4) history of recurrent pancreatitis, and 5) history of PEP. "Procedure-related risk factors"1) pancreatography, 2) endoscopic pancreatic sphincterotomy (EST), 3) pre-cut sphincteroromy, 4) difficulty of procerure (> 30 min), 5) dificulty of cannulation (> 6 times or > 15 min), 6) pancreatic tissue sampling, 7) biliary biopsy or brushing cytology, 8) intraductal ultrasonography (IDUS), 9) endoscopic balloon dilatation (EPBD), 10) endoscopic papillectomy (EP), 11) Self-expandable metallic stent (SEMS) placement and 12) trainee involvement in the ERCP.

Exclusion criteria

Exclusion criteria: 1) who we could not achieve informed concent, 2) who we evaluated inappropriate for thos trial, 3) who had poor performance status, 4) were under 20 years old, 5) to who ERCP was not completed, 6) who had acute or active pancreatitis, and 7) who had low risk factors of PEP: a) choronic pancreatitis, b) periodical stent exchange, c) ERC to pancreas divisum, and d) the past history of papilla disposal (ex. EST, EPBD and EP).

Design outcomes

Primary

MeasureTime frame
1) new abdominal pain. 2) eleuation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after ERCP. 3) extension of hospitalization or medical treatment at least two days.

Secondary

MeasureTime frame
adverse event

Countries

Japan

Contacts

Public ContactTakamitsu Sato

Yokohama City University Hospital Gastroenterology Division

tasatou-ykh@umin.ac.jp+81-45-787-2640

Outcome results

None listed

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