Clinical trial NCT04737642: Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation
Official title: Feasibility and Safety of Intraoperative Bile Duct Clearance by Sphincter of Oddi Balloon Dilatation: A Prospective Observational Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Choledocholithiasis
Surgery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful bile duct stone clearance (feasibility)
timeFrame: During operation, up to 2 hours
measure: Rate of successful bile duct stone clearance (feasibility)
timeFrame: At the 6 week follow up appointment
Secondary outcomes:
measure: Number of patients with injury to common bile duct
timeFrame: During operation, up to 2 hours
measure: Intraoperative blood loss
timeFrame: During operation, up to 2 hours
measure: Intraoperative blood substitution
timeFrame: During operation, up to 2 hours
measure: Number of patients with lesion to surrounding organs
timeFrame: During operation, up to 2 hours
measure: Number of patients with postoperative bile leak
timeFrame: From operation up to 6 weeks postoperative
measure: Number of patients with postoperative significant bleeding
timeFrame: From operation up to 6 weeks postoperative
measure: Number of patients with postoperative cholangitis
timeFrame: From operation up to 6 weeks postoperative
measure: Number of patients with postoperative lipasaemia
timeFrame: 4 hours after the operation
measure: Number of patients with postoperative acute pancreatitis
timeFrame: From operation up to 6 weeks postoperative
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern (Department for Visceral Surgery and Medicine)
Study officials:
affiliation: UVCM, Inselspital Bern
name: Beat Schnüriger, Prof
role: PRINCIPAL_INVESTIGATOR
References: