Pancreaticobiliary Reflux in Patients Without Cholelithiasis

Pancreaticobiliary Reflux Clinical Trial

Official title:

Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890201
• Other study ID #: HLS-2704009-02
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: December 1, 2010
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2010
• Source: Cirujanos la Serena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Gastroesophageal Reflux
• Pancreaticobiliary Reflux

Intervention

Procedure:
• Gallbladder bile sampling and intraoperative cholangiography
Interventions were exactly similar for both groups, and that is how it was intended to be: Gallbladder bile sampling: Sample 5 cc of gallbladder bile after the cystic duct has been clipped or ligated. Intraoperative cholangiography: Perform cholangiography before the cholecystectomy is finished

Locations

Country	Name	City	State
Chile	Hospital de La Serena	La Serena	Iv Region

Sponsors (1)

Lead Sponsor	Collaborator
Cirujanos la Serena

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Beltrán 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amylase and Lipase Values in Gallbladder Bile	Normal values of lipase and amylase in gallbladder bile should be zero	24 hours	No
Secondary	Amylase and Lipase Values in Normal Gallbladders		24 hours	No
Secondary	Amylase and Lipase Values in Gallbladders With Cholelithiasis		24 hours	No
Secondary	Normal Operative Cholangiography		24 hours	No
Secondary	Normal Preoperative Serum Values of Amylase and Lipase		24 hours	No

External Links

•   World Journal of Surgery 2010; 34:2915-2921 - DOI: 10.1007/s00268-010-0771-2