Clinical trial NCT00890201: Pancreaticobiliary Reflux in Patients Without Cholelithiasis
Official title: Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticobiliary Reflux
Keywords: Pancreaticobiliary reflux
Normal pancreaticobiliary junction
Gallstones
Cholelithiasis
Cholecystectomy
Lead sponsor: Cirujanos la Serena
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 197
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery.
2. Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases

Brief 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.

Detailed description: The objective of this study is to measure the levels of amylase and lipase in gallbladder bile of patients without gallstones and compare these values to the values of amylase and lipase of patients with gallstones and normal pancreaticobiliary union evidenced by intraoperative cholangiography.

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

Primary outcomes:
measure: Amylase and Lipase Values in Gallbladder Bile
timeFrame: 24 hours
Secondary outcomes:
measure: Amylase and Lipase Values in Normal Gallbladders
timeFrame: 24 hours
measure: Amylase and Lipase Values in Gallbladders With Cholelithiasis
timeFrame: 24 hours
measure: Normal Operative Cholangiography
timeFrame: 24 hours
measure: Normal Preoperative Serum Values of Amylase and Lipase
timeFrame: 24 hours
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Hospital de La Serena
state: Iv Region
Study officials:
affiliation: Hospital de La Serena
name: MARCELO A BELTRAN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beltran MA, Vracko J, Cumsille MA, Cruces KS, Almonacid J, Danilova T. Occult pancreaticobiliary reflux in gallbladder cancer and benign gallbladder diseases. J Surg Oncol. 2007 Jul 1;96(1):26-31. doi: 10.1002/jso.20756.
citation: Beltran MA, Contreras MA, Cruces KS. Pancreaticobiliary reflux in patients with and without cholelithiasis: is it a normal phenomenon? World J Surg. 2010 Dec;34(12):2915-21. doi: 10.1007/s00268-010-0771-2.