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OpenTrials
Completed

NCT Number: NCT00890201

Pancreaticobiliary Reflux in Patients Without Cholelithiasis

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.

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Key information

Conditions

Pancreaticobiliary Reflux Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de La Serena

La Serena, Coquimbo Region, IV REGION, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gallbladder bile sampling and intraoperative cholangiography

Procedure

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

Other names: Measurement of pancreaticobiliary reflux

Primary outcomes

  1. Amylase and Lipase Values in Gallbladder Bile

    Time frame: 24 hours

    Normal values of lipase and amylase in gallbladder bile should be zero

Secondary outcomes

  1. Amylase and Lipase Values in Normal Gallbladders

    Time frame: 24 hours

  2. Amylase and Lipase Values in Gallbladders With Cholelithiasis

    Time frame: 24 hours

  3. Normal Operative Cholangiography

    Time frame: 24 hours

  4. Normal Preoperative Serum Values of Amylase and Lipase

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Cirujanos la Serena

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2009
Registry last updated
Dec 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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