Pancreaticobiliary Reflux in Patients Without Cholelithiasis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreaticobiliary Reflux |
Procedure: Gallbladder bile sampling and intraoperative cholangiography |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon? |
- Amylase and Lipase Values in Gallbladder Bile [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Normal values of lipase and amylase in gallbladder bile should be zero
- Amylase and Lipase Values in Normal Gallbladders [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Amylase and Lipase Values in Gallbladders With Cholelithiasis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Normal Operative Cholangiography [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Normal Preoperative Serum Values of Amylase and Lipase [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 197 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. |
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 Other Name: Measurement of pancreaticobiliary reflux
|
|
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. |
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 Other Name: Measurement of pancreaticobiliary reflux
|
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| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery.
- Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases
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
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | MARCELO A. BELTRAN, M.D., HOSPITAL DE LA SERENA |
| ClinicalTrials.gov Identifier: | NCT00890201 History of Changes |
| Other Study ID Numbers: | HLS-2704009-02 |
| Study First Received: | April 28, 2009 |
| Results First Received: | July 27, 2009 |
| Last Updated: | December 1, 2010 |
| Health Authority: | Chile: Instituto de Salud Publica de Chile |
Keywords provided by Cirujanos la Serena:
|
Pancreaticobiliary reflux Normal pancreaticobiliary junction Gallstones Cholelithiasis Cholecystectomy |
Additional relevant MeSH terms:
|
Cholelithiasis Cholecystolithiasis Gallstones Gastroesophageal Reflux Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases |
Calculi Pathological Conditions, Anatomical Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013