Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05191693 |
| Other study ID # |
Paspatis-balloon dilation |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2018 |
| Est. completion date |
August 29, 2020 |
Study information
| Verified date |
January 2022 |
| Source |
Venizelio General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
