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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191693
Recruitment Status : Completed
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Gregorios Paspatis, Venizelio General Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Endoscopic Papillary Balloon Dilation Bile Duct Stones Endoscopic Sphincterotomy Stone Recurrence Procedure: ERCP

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.

Study Design
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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study
Actual Study Start Date : September 30, 2018
Actual Primary Completion Date : August 29, 2020
Actual Study Completion Date : August 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Group/Cohort Intervention/treatment
patients with CBD stones up to 8-12mm
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
 Procedure: ERCP
endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST
Other Name: endoscopic papillary balloon


Outcome Measures
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Primary Outcome Measures :
  1. Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP. [ Time Frame: 22.4±6.2 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 ,who were prospectively followed for at least 12 months
Criteria

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.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191693


Locations
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Greece
''Benizelion" General Hospital
Heraklion, Greece, 71409
Sponsors and Collaborators
Venizelio General Hospital
Investigators
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Study Director: Gregorios Gregorios, Director ''Benizelion" General Hospital, Heraklion, Crete
More Information
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Responsible Party: Gregorios Paspatis, director of the gastroenterology department of Venizelio General Hospital, Venizelio General Hospital
ClinicalTrials.gov Identifier: NCT05191693    
Other Study ID Numbers: Paspatis-balloon dilation
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregorios Paspatis, Venizelio General Hospital:
endoscopic papillary balloon dilation
Stone recurrence
Additional relevant MeSH terms:
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Recurrence
Calculi
Dilatation, Pathologic
 Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical