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Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial

Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial - Pancratic head vs pancreatic body/tail:into which region should a prophylactic pacreatic stent inserted in high risk patients: Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042395
Enrollment
200
Registered
2020-11-10
Start date
2020-11-10
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

High risk patient for post-ERCP pancreatitis (PEP)

Interventions

Insertion of a prophylactic pancreatic stent up to pancreatic body or tail Insertion of a prophylactic pancreatic stent in pancreatic head

Sponsors

Department of Gastroenterology, Fukushima Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The cases who were performed ERCP to investigate or treat pancreaticobiliary diseases. The patients has more than one of the below risk factors and are placed ERCP guidewire to main pancreatic duct. 1. Past history of pancreatitis 2. Endoscopic pancreatography 3. Precut of Vater papilla 3. The invasive pancreaticobiliary investigation (brush cytology, biopsy, IDUS, cygology of pancreatic juice, etc...) 4. The biliary metallic stent insertion

Exclusion criteria

Exclusion criteria: 1. Vater papilla that has already performed endoscopic procedures (EST, stenting, EPBD, etc) 2. The imposiblity of endoscopic access to Vater papilla 3. The past history of gastorectomy 4. Pancreas divism 5. Intraductal papillary mucinous neoplasm 6. Theraperutic pancreatic stent insertion 7. Chronic pancreatitis, pancreatic head cancer 8. Postampllectomy 9. Malfusion of pancreaticobiliary ducts 10. Allergies to drugs that are used in ERCP 11. Acute pancreatitis, or serum hyperamylasemia (pancratic isozyme more than 150 IU/L) 12. Not sufficiently sedated

Design outcomes

Primary

MeasureTime frame
The occurrance of PEP

Secondary

MeasureTime frame
1. The highest pancreatic isozyme of serum amylase within a week after ERCP 2. The comparison of ERCP rlated procedures (EST, Precut of Vater papilla, EPBD, endoscopic stone removal, biliary drainage, IDUS, pancratic investigation, the time of procedure)

Countries

Japan

Contacts

Public ContactMitsuru Sugimoto

School of Medicine, Fukushima Medical University Department of Gastroenterology

kita335@fmu.ac.jp+81-24-547-1111

Outcome results

None listed

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