NCT04025645

Common Bile Duct Pressures in Patients With and Without Cholelithiasis

Completed Last updated 22 July 2019

What this trial tests

trial testing MEASUREMENT OF COMMON BILE DUCT PRESSURES in Biliary Disease in 87 participants. Completed in 10 July 2019.

Timeline

1 January 2015

Primary endpoint
30 June 2017

10 July 2019

Quick facts

Lead sponsor	Hospital de La Serena
Status	Completed
Study type	OBSERVATIONAL
Enrollment	87
Start date	1 January 2015
Primary completion	30 June 2017
Estimated completion	10 July 2019

Drugs / interventions tested

• MEASUREMENT OF COMMON BILE DUCT PRESSURES

Conditions studied

• Biliary Disease — all drugs for Biliary Disease →

Sponsor

Hospital de La Serena

Who can join

Eligibility, any sex, with Biliary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.