N/A
N=197
Pancreaticobiliary Reflux in Patients Without Cholelithiasis
Pancreaticobiliary Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00890201 ↗Enrolled (actual)
197
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Amylase and Lipase Values in Gallbladder Bile — 5.5; 181.2; 9.5; 434.8 mg/dl
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gallbladder bile sampling and intraoperative cholangiography (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Cirujanos la Serena
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amylase and Lipase Values in Gallbladder Bile |
5.5; 181.2; 9.5; 434.8 | — |
| SECONDARY Amylase and Lipase Values in Normal Gallbladders |
— | — |
| SECONDARY Amylase and Lipase Values in Gallbladders With Cholelithiasis |
— | — |
| SECONDARY Normal Operative Cholangiography |
— | — |
| SECONDARY Normal Preoperative Serum Values of Amylase and Lipase |
— | — |
Summary
Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union. However, the presence of pancreaticobiliary reflux has not been studied in patients without gallstones (healthy gallbladders).
The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients with and without gallstones, although in patients with cholelithiasis it might constitute a pathological condition associated with dismotility of the biliary tree and the sphincter of Oddi.
Eligibility Criteria
Inclusion Criteria
- Age older than 15 years of age
- Elective surgery
- Normal intraoperative cholangiography
- Normal preoperative serum amylase and lipase values
Exclusion Criteria
- Common bile duct stones
- Anatomic anomalies at the pancreaticobiliary junction evidenced by intraoperative cholangiography
- Altered preoperative amylase and lipase levels
- Altered preoperative hepatic function tests
- Emergency surgery
Data sourced from ClinicalTrials.gov (NCT00890201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.