Common Bile Duct Pressures in Patients With and Without Cholelithiasis

Sponsor

Hospital de La Serena (Other)

Overall Status

Completed

CT.gov ID

NCT04025645

Collaborator

(none)

Enrollment

54.2

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Disease	Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES

Detailed Description

A prospective study of cases and controls was designed using a previously validated model for the study of occult pancreatobiliary reflux in patients undergoing gastrectomy for gastric cancer, in which cholecystectomy is routine according to the oncological surgery protocol for gastric cancer of our institution. The study universe was constituted by a convenience sample in which all patients undergoing gastrectomy for gastric cancer during the period between January 2015 and June 2017 the investigators included. All patients included in this study signed a detailed informed consent regarding the interventions to be performed and the objectives of the study.

Cholecystectomy was performed in all patients after the section of the duodenum. Before the manipulation and dissection of the Calot triangle, a sample of 5 to 10 cc of bile was taken directly from the gallbladder. The sample was stored in a sterile tube at room temperature and immediately sent for processing. The technicians of our institutional laboratory that processed the sample did not know the details of the study. The cholecystectomy was then carried out until the cystic was reached and was cut as proximally as possible to the gallbladder. Through the cystic duct, a 4 French feeding tube equivalent to 1.35 mm in diameter (Well Lead®, Hamburg, Germany) was introduced until reaching a distance of 3 cm distal to the junction of the cystic duct and the common bile duct. Once tested for patency, this probe was connected to a standard pressure transducer used to measure intra-arterial pressure (Edwards Lifesciences™, Irvine, California, USA) and this was connected to a B40 monitor (General Electric® Medical Systems, Milwaukee, WI, USA) with the ability, among other functions, to perform pressure measurements in millimeters of mercury. The level of the junction of the cystic duct and the common bile duct was taken as a zero point, as previously described. Once the whole system was irrigated with 0.9% physiological solution and the zero point was established on the monitor with the system closed, the system was opened and pressures were measured. The minimum, maximum and mean pressures were recorded for one minute. After the procedure was completed, the gastrectomy was performed.

Study Design

Study Type:

Observational

Actual Enrollment :

87 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Common Bile Duct Pressures in Patients With and Without Cholelithiasis: A Cases and Controls Study

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jul 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
PATIENTS WITH CHOLELITHIASIS COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITH CHOLELITHIASIS	Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED
PATIENTS WITHOUT CHOLELITHIASIS COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITHOUT CHOLELITHIASIS	Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED

Arm

Intervention/Treatment

PATIENTS WITH CHOLELITHIASIS

COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITH CHOLELITHIASIS

Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES

THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED

PATIENTS WITHOUT CHOLELITHIASIS

COMMON BILE DUCT PRESSURES WERE MEASURED IN PATIENTS WITHOUT CHOLELITHIASIS

Diagnostic Test: MEASUREMENT OF COMMON BILE DUCT PRESSURES

THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED

Outcome Measures

Primary Outcome Measures

Common bile duct pressures [Two and a half years]
Establish differences between common bile duct pressures in patients with and without gallstones

Secondary Outcome Measures

Levels of amylase and lipase in bile [Two and a half years]
Establish the relationship between these pressure differences and the presence of pancreatobiliary reflux in patients with and without cholelithiasis