Common Bile Duct Pressures in Patients With and Without Cholelithiasis

NCT04025645 | Completed DMC

• 1 other identifier: HLS-MBS-001
• Study Type: observational
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective. To measure the pressures of the common bile duct in patients with and without cholelithiasis and relating them to the presence of pancreatobiliary reflux. Summary Background Data. The reflux of pancreatic enzymes into the epithelium of the bile duct and mainly of the gallbladder is an abnormal phenomenon that plays a role in the lithogenesis and carcinogenesis of this epithelium. It has been suggested that the cause of this reflux is the dysfunction of the sphincter of Oddi. Because the pressure of the common bile duct depends on the pressures of the sphincter of Oddi, this dysfunction would be reflected in an increase in the pressure of the common bile duct in patients with cholelithiasis. Methods. A prospective case-control study was designed. The universe was constituted by a convenience sample in which all patients undergoing gastrectomy for gastric cancer during 30 months in our institution were included. The primary outcome measure was to establish differences between common bile duct pressures in patients with and without cholelithiasis. Results. Common bile duct pressures in patients with gallstones showed a significant elevation (Mean 16.9 mmHg) compared to those of patients without gallstones (Mean 3.3 mm Hg) (p\<0.0001). These pressures correlated with the values of amylase and lipase in gallbladder bile; higher levels of these enzymes were found in patients with gallstones compared to patients without gallstones (p\<0.0001). Conclusions. Common bile duct pressures in patients with cholelithiasis were significantly elevated above the parameters previously considered normal.

Conditions

Biliary Disease

Keywords

Cholelithiasis; Common Bile Duct; Sphincter of Oddi; Amylase; Lipase

Outcome Measures

Primary Outcomes (1)

• Common bile duct pressures

  Establish differences between common bile duct pressures in patients with and without gallstones

  Two and a half years

Secondary Outcomes (1)

• Levels of amylase and lipase in bile

  Two and a half years

Study Arms (2)

PATIENTS WITH CHOLELITHIASIS

COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITH CHOLELITHIASIS

Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES

PATIENTS WITHOUT CHOLELITHIASIS

COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITHOUT CHOLELITHIASIS

Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES

Interventions

MEASUREMENT OF COMMON BILE DUCT PRESSURES DIAGNOSTIC_TEST

THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED

PATIENTS WITH CHOLELITHIASIS; PATIENTS WITHOUT CHOLELITHIASIS

Eligibility Criteria

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

Study Population

Patients with gastric cancer undergoing elective surgery

You may qualify if:

• All patients with normal values of amylase, lipase, and liver function tests measured 24 hours before the intervention

You may not qualify if:

• Patients previously cholecystectomized
• Patients with clinical, radiological and laboratory evidence of common bile duct stones

Sponsors & Collaborators

• Hospital de La Serena: lead

MeSH Terms

Conditions

Gallbladder Diseases; Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Digestive surgeon

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: January 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: July 10, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share