Pancreaticobiliary Reflux in Patients Without Cholelithiasis
NCT ID: NCT00890201
Last Updated: 2010-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
197 participants
OBSERVATIONAL
2009-01-31
2009-07-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal Gallbladder
Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal.
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
Gallbladder with gallstones
Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).
The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective surgery
* Normal intraoperative cholangiography
* Normal preoperative serum amylase and lipase values
Exclusion Criteria
* Anatomic anomalies at the pancreaticobiliary junction evidenced by intraoperative cholangiography
* Altered preoperative amylase and lipase levels
* Altered preoperative hepatic function tests
* Emergency surgery
15 Years
ALL
No
Sponsors
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Cirujanos la Serena
OTHER
Responsible Party
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HOSPITAL DE LA SERENA
Principal Investigators
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MARCELO A BELTRAN, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital de La Serena
Locations
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Hospital de La Serena
La Serena, Coquimbo Region, Chile
Countries
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References
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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.
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.
Other Identifiers
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HLS-2704009-02
Identifier Type: -
Identifier Source: org_study_id