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Comparison between room water versus cold water in preventing post-ERCP pancreatitis : A Randomized Double-blinded Controlled Trail

Comparison between room water versus cold water in preventing post-ERCP pancreatitis : A Randomized Double-blinded Controlled Trail

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260601028
Enrollment
442
Registered
2026-06-01
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Post ERCP pancreatitis Prevention of post-ERCP pancreatitis : between room water versus cold water ERCP - related complication : bleeding,perforation,death Post ERCP pain ERCP Post ERCP pancreatitis PEP Cold water Room water Water irrigation Pancreatitis prevention Endoscopic retrograde cholangiopancreatography Randomized controlled trail

Interventions

Cold water irrgation was administered after ERCP using sterile water at approximately 2-8 celcius,Room water irrgation was administered after ERCP using sterile room water
Cold water irrigation,Room water irrigation

Sponsors

Tha gastroenterological associated of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > 20 year old with Indication for ERCP 2. Choledocholithiasis 3. Benign biliary stricture or Malignant biliary stricture 4. Cholangitis 5. Cholecystitis 6. Gall bladder tumor 7. IPMN 8. Suspected of sphincter of oddi dysfunction (SOD)

Exclusion criteria

Exclusion criteria: 1. Declined participant in the study 2. History of previous ERCP 3. Cancer with ECOG score = 4 4. History of duodenal obstruction 5. History of Postoperative reconstructed intestinal tract 6. History of Acute or chronic pancreatitis 7. Pancreatic head cancer 8. Papillary tumor

Design outcomes

Primary

MeasureTime frame
Incidence of post ERCP pancreatitis after 24 hours post ERCP to compare the efficacy of cold water versus room water temperature 24 hours after ERCP Cotton criteria for post ERCP pancreatitis

Secondary

MeasureTime frame
Incidence of post ERCP complication bleeding,perforation,death / post ERCP abdominal pain, level amylase lipase 24 hours after ERCP pain measurement scale, serum amylase and lipase measurement

Countries

Thailand

Contacts

Public ContactSupavit Koonthaveesap

Division of Gastroenterology and hepatology Department of internal medicine Phramonkutklao hospital

Supavit_PCM@hotmail.com0865195090

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026