Pancreaticobiliary Reflux in Patients Without Cholelithiasis
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| ClinicalTrials.gov Identifier: NCT00890201 |
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Recruitment Status :
Completed
First Posted : April 29, 2009
Results First Posted : October 20, 2009
Last Update Posted : December 17, 2010
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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 or disease | Intervention/treatment |
|---|---|
| Pancreaticobiliary Reflux | Procedure: Gallbladder bile sampling and intraoperative cholangiography |
| Study Type : | Observational |
| Actual Enrollment : | 197 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Is Pancreaticobiliary Reflux in Patients With Cholelithiasis and Without Cholelithiasis a Normal Phenomenon? |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | July 2009 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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. |
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 |
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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 |
- Amylase and Lipase Values in Gallbladder Bile [ Time Frame: 24 hours ]Normal values of lipase and amylase in gallbladder bile should be zero
- Amylase and Lipase Values in Normal Gallbladders [ Time Frame: 24 hours ]
- Amylase and Lipase Values in Gallbladders With Cholelithiasis [ Time Frame: 24 hours ]
- Normal Operative Cholangiography [ Time Frame: 24 hours ]
- Normal Preoperative Serum Values of Amylase and Lipase [ Time Frame: 24 hours ]
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890201
| Chile | |
| Hospital de La Serena | |
| La Serena, Iv Region, Chile, IV REGION | |
| Principal Investigator: | MARCELO A BELTRAN, M.D. | Hospital de La Serena |
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 |
| Other Study ID Numbers: |
HLS-2704009-02 |
| First Posted: | April 29, 2009 Key Record Dates |
| Results First Posted: | October 20, 2009 |
| Last Update Posted: | December 17, 2010 |
| Last Verified: | September 2010 |
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Pancreaticobiliary reflux Normal pancreaticobiliary junction Gallstones Cholelithiasis Cholecystectomy |
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Gastroesophageal Reflux Cholelithiasis Cholecystolithiasis Gallstones Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Biliary Tract Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |