Retrospective Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Aug 16, 2022; 14(8): 487-494
Published online Aug 16, 2022. doi: 10.4253/wjge.v14.i8.487
Percutaneous transluminal angioplasty balloons for endoscopic ultrasound-guided pancreatic duct interventions
Jad P AbiMansour, Barham K Abu Dayyeh, Michael J Levy, Andrew C Storm, John A Martin, Bret T Petersen, Ryan J Law, Mark D Topazian, Vinay Chandrasekhara
Jad P AbiMansour, Barham K Abu Dayyeh, Michael J Levy, Andrew C Storm, John A Martin, Bret T Petersen, Ryan J Law, Mark D Topazian, Vinay Chandrasekhara, Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, United States
Author contributions: AbiMansour JP collected the data, performed the analysis and wrote the paper; Abu Dayyeh BK, Levy MJ, Storm AC, Martin JA, Petersen BT, Law RJ, and Topazian MD performed the procedures, obtained the data, and critically reviewed the manuscript; and Chandrasekhara VC designed the research and provided supervision, manuscript review, and final approval.
Institutional review board statement: This study was reviewed and approved by the Mayo Clinic Institutional Review Board (IRB No. 20-0055740).
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: Andrew C Storm is a consultant for Apollo Endosurgery; and received research support from Apollo Endosurgery and Boston Scientific. Ryan J Law is a consultant for ConMed and Medtronic and receives royalties from UpToDate. Bret T Petersen is a consultant for Olympus America and investigator for Boston Scientific and Ambu. Barham K Abu Dayyeh reports consultant roles with Endogenex, Endo-TAGSS, Metamodix, and BFKW; consultant and grant or research support from USGI, Cairn Diagnostics, Aspire Bariatrics, Boston Scientific; speaker roles with Olympus, Johnson and Johnson; speaker and grant or research support from Medtronic, Endogastric solutions; and research support from Apollo Endosurgery and Spatz Medical. Vinay Chandrasekhara is a consultant for Covidien LP, is on the advisory board for Interpace Diagnostics, and is a shareholder in Nevakar, Inc. The remaining authors have no conflicts or funding to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Vinay Chandrasekhara, FASGE, MD, Associate Professor, Department of Gastroenterology and Hepatology, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States. chandrasekhara.vinay@mayo.edu
Received: February 14, 2022
Peer-review started: February 14, 2022
First decision: April 5, 2022
Revised: April 19, 2022
Accepted: July 22, 2022
Article in press: July 22, 2022
Published online: August 16, 2022
Processing time: 181 Days and 15.4 Hours
ARTICLE HIGHLIGHTS
Research background

While endoscopic retrograde cholangiopancreatography (ERCP) remains the gold standard for main pancreatic duct (MPD) intervention, endoscopic ultrasound (EUS)-guided MPD access has emerged as a safe and effective alternative when ERCP fails. A key step in EUS-guided intervention is dilation of the tract created between the gastrointestinal lumen and pancreatic duct, however there is limited data regarding the optimal dilation device and technique. Furthermore, current tools were designed primarily for biliary intervention, including hydrostatic balloons, tapered bougies, and electrocautery-enhanced catheters.

Research motivation

A small diameter, hydrostatic balloon would theoretically allow for safe dilation while minimizing the risk of adverse events, however commercially available devices are limited. Percutaneous angioplasty balloons (PTABs) are small diameter balloons that were initially designed for vascular interventions. They can be deployed over a standard guidewire and utilized on endoscopic platforms to dilate the access tract created during EUS-guided access as well as high grade strictures. However, data on the use of these devices is limited to a handful of case reports.

Research objectives

The main objective of this study is to describe the efficacy and safety of PTAB use during EUS-guided MPD access. The primary outcome was technical success with secondary outcomes of clinical success and adverse event rate. The objectives of this study provide key, real-word information on the use of PTABs for clinicians as well as preliminary data to inform future prospective studies.

Research methods

This is a retrospective, single center cohort study performed at an academic tertiary care center which includes all patients from 2011 to 2021 who underwent EUS-guided MPD which utilized a PTAB. Patients were identified retrospectively from a procedural supply database and clinical information was extracted from the electronic medical record.

Research results

A total of 23 cases were identified. Intervention was performed in the setting of chronic pancreatitis in 13 (56%), post-surgical stricture in 8 (35%), and post-surgical leak in 2 (9%). Technical success was achieved in 20 (87%) cases with 6 (26%) adverse events. Adverse events were all mild in severity and included 3 admissions for post-procedural pain, 2 pancreatitis, and 1 pancreatic duct leak.

Research conclusions

This study demonstrates that PTABs can be used to consistently access the MPD for EUS-guided interventions with an acceptable safety profile. In the absence of dedicated devices, endoscopists can consider using cross-platform PTABs for initial dilation prior to antegrade interventions.

Research perspectives

Further prospective, randomized studies are needed to compare the efficacy and safety of PTABs to other dilating devices and techniques.