Pancreaticobiliary Reflux in Patients Without Cholelithiasis

NCT00890201 | Completed Results

• 1 other identifier: HLS-2704009-02
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreaticobiliary Reflux

Keywords

Pancreaticobiliary reflux; Normal pancreaticobiliary junction; Gallstones; Cholelithiasis; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Amylase and Lipase Values in Gallbladder Bile

  Normal values of lipase and amylase in gallbladder bile should be zero

  24 hours

Secondary Outcomes (4)

• 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

Study Arms (2)

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

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

Gallbladder bile sampling and intraoperative cholangiography PROCEDURE

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

Also known as: Measurement of pancreaticobiliary reflux

Gallbladder with gallstones; Normal Gallbladder

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with gallstones (symptomatic cholelithiasis) submitted to elective surgery. 2. Patients without gallstones submitted to elective surgery for benign or malignant gastroesophageal diseases

You may qualify if:

• Age older than 15 years of age
• Elective surgery
• Normal intraoperative cholangiography
• Normal preoperative serum amylase and lipase values

You may not qualify if:

• 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

Sponsors & Collaborators

• Cirujanos la Serena: lead

Study Sites (1)

Hospital de La Serena

La Serena, Coquimbo Region, IV REGION, Chile

Location

Related Publications (2)

• 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.

  PMID: 17345616 BACKGROUND

• 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.

  PMID: 20811747 DERIVED

MeSH Terms

Conditions

Gallstones; Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marcelo A. Beltran, M.D. - Department of Surgery - Hospital de La Sererna
• Organization: Hospital de La Serena

beltran_01@yahoo.com

56 51 485923

Study Officials

• MARCELO A BELTRAN, M.D.

  Hospital de La Serena

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 17, 2010
• Results First Posted: October 20, 2009

Record last verified: 2010-09

Locations

CL (1)