Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation (TCPBD)

January 24, 2023 updated by: University Hospital Inselspital, Berne

Feasibility and Safety of Intraoperative Bile Duct Clearance by Sphincter of Oddi Balloon Dilatation: A Prospective Observational Pilot Study

To investigate feasibility and safety of intraoperative bile duct clearance by sphincter of Oddi balloon dilatation via cystic duct at cholecystectomy.

Primary endpoint: rate of successful bile duct stone clearance (feasibility). Secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). Duration of procedure. Length of hospital stay.

Study Overview

Detailed Description

Standard approach to address common bile duct stones is endoscopic retrograde cholangiography (ERC) with sphincterotomy. Those interventions are performed either before or after gallbladder removal (cholecystectomy), thus, requiring at least two interventions. Moreover, ERC with sphincterotomy is associated with a considerable rate of short and long-term morbidity. The main complications are pancreatitis (2-7%), post sphincterotomy bleeding (1-2%), impaired function of the sphincter with reflux of duodenal content to the bile ducts and a consecutive risk for cholangitis, stone recurrence and even a potential higher risk for cholangiocarcinoma.

The aim of this study is to evaluate an alternative surgical approach of bile duct clearance at the time of cholecystectomy. Literature of this approach is scarce; however, it has shown a trend to lower postoperative complications if compared to ERC. The technique of sphincter of Oddi balloon dilatation and bile duct clearance from stones via cystic duct at cholecystectomy has been described in a few case series. These small case series have shown a good success rate of bile stone clearance and low complication rates when applying the balloon dilation technique for smaller stones.

The investigators have used this technique in selected cases with good success as well. However, the technique needs to be assessed regarding feasibility and safety in a consecutive group of patients.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bern, Switzerland, 3010
        • Inselspital Bern (Department for Visceral Surgery and Medicine)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Patients ≥ 18 years of age
  • Patients with gallbladder stones and known or expected concomitant bile duct stones
  • Bile duct stones ≤ 6mm in size measured by intraoperative cholangiography

Exclusion Criteria:

  • Women who are pregnant
  • Declined consent
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Patients with moderate or severe acute cholangitis
  • Patients with moderate or severe pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Papillary ballon dilatation
Trans cystic papillary ballon dilatation during cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of successful bile duct stone clearance (feasibility)
Time Frame: During operation, up to 2 hours
Intraoperative cholangiogram showing no persistent stones in the common bile duct after the study procedure
During operation, up to 2 hours
Rate of successful bile duct stone clearance (feasibility)
Time Frame: At the 6 week follow up appointment
Patient not showing any signs of choledocholithiasis (fever, pale stool, dark urine, right upper quadrant pain, elevated cholestasis parameters) at 6 week follow up
At the 6 week follow up appointment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with injury to common bile duct
Time Frame: During operation, up to 2 hours
Injury to common bile duct is defined as contrast agent leakage from common bile duct during cholangiography or an obvious lesion.
During operation, up to 2 hours
Intraoperative blood loss
Time Frame: During operation, up to 2 hours
Measured in ml
During operation, up to 2 hours
Intraoperative blood substitution
Time Frame: During operation, up to 2 hours
Number of erythrocyte concentrates (275ml each)
During operation, up to 2 hours
Number of patients with lesion to surrounding organs
Time Frame: During operation, up to 2 hours
stomach, duodenum, liver, small bowel, colon
During operation, up to 2 hours
Number of patients with postoperative bile leak
Time Frame: From operation up to 6 weeks postoperative
Bile leakage is defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or biliary peritonitis
From operation up to 6 weeks postoperative
Number of patients with postoperative significant bleeding
Time Frame: From operation up to 6 weeks postoperative
Significant bleeding is defined as a drop in haemoglobin level > 3 g/dl post-operatively compared with the post-operative baseline level and/or any post-operative transfusion of packed red blood cells for a falling haemoglobin and/or the need for radiological intervention (such as embolization) and/or re-operation to stop bleeding
From operation up to 6 weeks postoperative
Number of patients with postoperative cholangitis
Time Frame: From operation up to 6 weeks postoperative
Cholangitis is defined according to the Tokyo Guidelines 2018 [17]: The guidelines encompass systemic TCPBD-Pilot-Tr ial Version 4.0 of 14.09.2020 Page 29 of 41 inflammation (fever, chills or increased inflammatory markers), cholestasis (jaundice or abnormal liver function tests) and imaging (biliary dilation or evidence of stricture, stone or stent). Diagnosis can be suspected in cases of systemic inflammation and one of the two other parameters. Diagnosis is confirmed if all three parameters are present.
From operation up to 6 weeks postoperative
Number of patients with postoperative lipasaemia
Time Frame: 4 hours after the operation
Lipasaemia is defined as elevation in serum lipase to ten times or greater than the upper limit of normal. It is measured 4 hours after the intervention
4 hours after the operation
Number of patients with postoperative acute pancreatitis
Time Frame: From operation up to 6 weeks postoperative
The diagnosis of acute pancreatitis is defined by the presence of two of the following three criteria: acute onset of persistent, severe, epigastric pain often radiating to the back, elevation in serum lipase or amylase to three times or greater than the upper limit of normal, and characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography, magnetic resonance imaging, or transabdominal ultrasonography)
From operation up to 6 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Beat Schnüriger, Prof, UVCM, Inselspital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

October 9, 2022

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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