NCT00890201|CompletedResults
Pancreaticobiliary Reflux in Patients Without Cholelithiasis
Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?
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Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon?
Sponsor study identifier
observational
197
1 country
1
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
July 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 28, 2009
Actual (reported)April 29, 2009
Actual (reported)July 2009
Actual (reported)July 2009
Actual (reported)October 20, 2009
Actual (reported)Amylase and Lipase Values in Gallbladder Bile
Normal values of lipase and amylase in gallbladder bile should be zero
24 hours
Amylase and Lipase Values in Normal Gallbladders
24 hours
Amylase and Lipase Values in Gallbladders With Cholelithiasis
24 hours
Normal Operative Cholangiography
24 hours
Normal Preoperative Serum Values of Amylase and Lipase
24 hours
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.
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.
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
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1. Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery. 2. Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases
Hospital de La Serena
La Serena, Coquimbo Region, IV REGION, Chile
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.
MARCELO A BELTRAN, M.D.
Hospital de La Serena
197 participants (actual enrollment reported by the registry).
First Submitted
April 28, 2009
First Posted
April 29, 2009
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
July 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
December 17, 2010
Results First Posted
October 20, 2009
Record last verified: 2010-09
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Source: ClinicalTrials.gov.
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