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CompletedNCT04025645Updated Jul 22, 2019

Common Bile Duct Pressures in Patients With and Without Cholelithiasis

An observational study in Biliary Disease, sponsored by Hospital de La Serena. Completed. Per ClinicalTrials.gov, last updated 2019-07-22.

Sponsored by Hospital de La Serena · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
87
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Biliary Disease

Keywords

  • Cholelithiasis
  • Common Bile Duct
  • Sphincter of Oddi
  • Amylase
  • Lipase
03

In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 87 is below the median of 200 across 83 observational studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

This is the only study on the registry with Hospital de La Serena as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with gastric cancer undergoing elective surgery

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients previously cholecystectomized
  • Patients with clinical, radiological and laboratory evidence of common bile duct stones
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
87 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testMEASUREMENT OF COMMON BILE DUCT PRESSURES

    THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED

06

What researchers measure

Primary outcomes

  1. Common bile duct pressures

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

    Time frame: Two and a half years

Secondary outcomes

  1. Levels of amylase and lipase in bile

    Establish the relationship between these pressure differences and the presence of pancreatobiliary reflux in patients with and without cholelithiasis

    Time frame: Two and a half years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04025645
Lead sponsor
Hospital de La Serena
Responsible party
MARCELO BELTRAN (Digestive surgeon, Hospital de La Serena) — Principal investigator
First posted
Jul 19, 2019
Start date
Jan 1, 2015
Primary completion
Jun 30, 2017
Completion
Jul 10, 2019
Last update
Jul 22, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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