NCT04737642

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

December 24, 2020

Last Update Submit

January 24, 2023

Conditions

CholecystolithiasisCholedocholithiasisSurgery

Outcome Measures

Primary Outcomes (2)

  • Rate of successful bile duct stone clearance (feasibility)

    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)

    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 Outcomes (9)

  • Number of patients with injury to common bile duct

    During operation, up to 2 hours

  • Intraoperative blood loss

    During operation, up to 2 hours

  • Intraoperative blood substitution

    During operation, up to 2 hours

  • Number of patients with lesion to surrounding organs

    During operation, up to 2 hours

  • Number of patients with postoperative bile leak

    From operation up to 6 weeks postoperative

  • +4 more secondary outcomes

Study Arms (1)

Papillary ballon dilatation

EXPERIMENTAL
Procedure: Papillary ballon dilatation

Interventions

Papillary ballon dilatationPROCEDURE

Trans cystic papillary ballon dilatation during cholecystectomy

Papillary ballon dilatation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital Bern (Department for Visceral Surgery and Medicine)

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37962117DERIVED

MeSH Terms

Conditions

CholecystolithiasisCholedocholithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesCommon Bile Duct DiseasesBile Duct Diseases

Study Officials

  • Beat Schnüriger, Prof

    UVCM, Inselspital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2020

First Posted

February 4, 2021

Study Start

January 4, 2021

Primary Completion

July 1, 2022

Study Completion

October 9, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)