Pancreaticobiliary Reflux
Conditions
Keywords
Pancreaticobiliary reflux, Normal pancreaticobiliary junction, Gallstones, Cholelithiasis, Cholecystectomy
Brief 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.
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.
Interventions
PROCEDUREGallbladder 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
Sponsors
Cirujanos la Serena
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amylase and Lipase Values in Gallbladder Bile | 24 hours | Normal values of lipase and amylase in gallbladder bile should be zero |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Chile
Participant flow
Recruitment details
Patients recruited at the Department of Surgery of the Hospital de La Serena from January 2009 to July 2009
Pre-assignment details
Patients submitted to elective cholecystectomy for symptomatic gallstone disease, older than 16 years of age and patients submitted to elective gastrectomy for gastric cancer harboring normal gallbladders (without gallstones), were included in this trial. Patients within any other clinical situation were excluded
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 159 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 5 | 56 |
Baseline characteristics
| Characteristic | Gallbladder With Gallstones | Normal Gallbladder | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 8 Participants | 5 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 33 Participants | 182 Participants |
| Age Continuous | 43.4 years STANDARD_DEVIATION 12.6 | 55.4 years STANDARD_DEVIATION 10 | 46.3 years STANDARD_DEVIATION 13 |
| Region of Enrollment Chile | 159 participants | 38 participants | 197 participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Male | 140 Participants | 17 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Amylase and Lipase Values in Gallbladder Bile
Normal values of lipase and amylase in gallbladder bile should be zero
Time frame: 24 hours
Population: The number of participants analyzed was determined by the number of participants that matched the inclusion criteria. As posted elsewhere some participants were excluded from this analysis based in the exclusion criteria of the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Gallbladder | Amylase and Lipase Values in Gallbladder Bile | Amylase | 5.5 mg/dl | Standard Deviation 16.4 |
| Normal Gallbladder | Amylase and Lipase Values in Gallbladder Bile | Lipase | 9.5 mg/dl | Standard Deviation 16.6 |
| Gallbladder With Gallstones | Amylase and Lipase Values in Gallbladder Bile | Amylase | 181.2 mg/dl | Standard Deviation 352 |
| Gallbladder With Gallstones | Amylase and Lipase Values in Gallbladder Bile | Lipase | 434.8 mg/dl | Standard Deviation 1224 |
Secondary
Amylase and Lipase Values in Gallbladders With Cholelithiasis
Time frame: 24 hours
Secondary
Amylase and Lipase Values in Normal Gallbladders
Time frame: 24 hours
Secondary
Normal Operative Cholangiography
Time frame: 24 hours
Secondary
Normal Preoperative Serum Values of Amylase and Lipase
Time frame: 24 hours