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CholecystolithiasisTCPBDNCT04737642

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

A study testing Papillary ballon dilatation in people with Cholecystolithiasis and Choledocholithiasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholecystolithiasis, Choledocholithiasis, Surgery
What is being tested?
Papillary ballon dilatation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteSwitzerland
Study dates
4 Jan 2021to 9 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Inselspital Bern (Department for Visceral Surgery and Medicine)

    Bern, 3010

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
Papillary ballon dilatation
Medical subject headings
Cholecystolithiasis, Choledocholithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Papillary ballon dilatationProcedure or surgery

    Trans cystic papillary ballon dilatation during cholecystectomy

Study groups in NCT04737642
Study groupRoleWhat they receive
Papillary ballon dilatationExperimentalNot described
Receives: Procedure: Papillary ballon dilatation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of successful bile duct stone clearance (feasibility)

    Intraoperative cholangiogram showing no persistent stones in the common bile duct after the study procedure

    Measured: During operation, up to 2 hours

  2. Rate of successful bile duct stone clearance (feasibility)

    Patient not showing any signs of choledocholithiasis (fever, pale stool, dark urine, right upper quadrant pain, elevated cholestasis parameters) at 6 week follow up

    Measured: At the 6 week follow up appointment

Secondary outcomes (9)

  1. Number of patients with injury to common bile duct

    Injury to common bile duct is defined as contrast agent leakage from common bile duct during cholangiography or an obvious lesion.

    Measured: During operation, up to 2 hours

  2. Intraoperative blood loss

    Measured in ml

    Measured: During operation, up to 2 hours

  3. Intraoperative blood substitution

    Number of erythrocyte concentrates (275ml each)

    Measured: During operation, up to 2 hours

  4. Number of patients with lesion to surrounding organs

    stomach, duodenum, liver, small bowel, colon

    Measured: During operation, up to 2 hours

  5. Number of patients with postoperative bile leak

    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

    Measured: From operation up to 6 weeks postoperative

  6. Number of patients with postoperative significant bleeding

    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

    Measured: From operation up to 6 weeks postoperative

  7. Number of patients with postoperative cholangitis

    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.

    Measured: From operation up to 6 weeks postoperative

  8. Number of patients with postoperative lipasaemia

    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

    Measured: 4 hours after the operation

  9. Number of patients with postoperative acute pancreatitis

    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)

    Measured: From operation up to 6 weeks postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start4 Jan 2021
  3. Primary completion1 Jul 2022
  4. Study completion9 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04737642
Sponsor's protocol ID
BASEC 2020-01066
Acronym
TCPBD
Status last verified
Jan 2023
First submitted
24 Dec 2020
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prevost GA, Huber C, Schnell B, Candinas D, Wiest R, Schnuriger B. Feasibility and safety of intraoperative bile duct clearance by antegrade transcystic balloon sphincteroplasty: A prospective observational pilot study. J Trauma Acute Care Surg. 2024 Apr 1;96(4):666-673. doi: 10.1097/TA.0000000000004196. Epub 2023 Nov 13.

    PubMed 37962117

Questions about this trial

What is this clinical trial studying?

A study testing Papillary ballon dilatation in people with Cholecystolithiasis and Choledocholithiasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of successful bile duct stone clearance (feasibility) (time frame: During operation, up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.

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