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Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study

Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05191693
Enrollment
72
Registered
2022-01-13
Start date
2018-09-30
Completion date
2020-08-29
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Stones, Endoscopic Papillary Balloon Dilation, Endoscopic Sphincterotomy, Stone Recurrence

Keywords

endoscopic papillary balloon dilation, Stone recurrence

Brief summary

The investigators prospectively evaluated long-term outcomes of ELBPD+EST for CBD stones up to 8-12mm. EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.

Detailed description

Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm. Overall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST. The mean CBD diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). Post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. Mild cholangitis occurred in two cases. No cases with perforation or PEP were observed. During a mean follow-up of 22.4±6.2 months (range 13-36), CBD stones recurred in 2/72 (2.7%). EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.

Interventions

PROCEDUREERCP

endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST

Sponsors

Venizelio General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

patients with ELBPD+EST for CBD stones up to 8-12mm from September 2018 to August 2020 -

Exclusion criteria

Patients with bile duct stones less than 8mm or more than 12mm. \-

Design outcomes

Primary

MeasureTime frameDescription
Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP.22.4±6.2 monthsPatients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026