Per-oral pancreatoscopy-guided lithotripsy vs. extracorporeal shock wave lithotripsy for treating refractory main pancreatic duct stones in chronic pancreatitis: Protocol for an open-label multi-center randomized clinical trial.
Humans
Quality of Life
Cholangiopancreatography, Endoscopic Retrograde
/ methods
Treatment Outcome
Calculi
/ therapy
Pancreatic Ducts
Lithotripsy
/ methods
Pancreatitis, Chronic
/ complications
Pancreatic Diseases
/ complications
Pain
/ complications
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Chronic pancreatitis
Electrohydraulic lithotripsy
Extracorporeal shock-wave lithotripsy
Laser lithotripsy
Pancreatic duct stone
Journal
Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]
ISSN: 1424-3911
Titre abrégé: Pancreatology
Pays: Switzerland
ID NLM: 100966936
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
23
01
2022
revised:
26
08
2022
accepted:
29
09
2022
pubmed:
24
10
2022
medline:
7
12
2022
entrez:
23
10
2022
Statut:
ppublish
Résumé
Patients with chronic pancreatitis may develop pancreatic duct stones that can obstruct outflow leading to ductal hypertension and pain. Both endoscopic retrograde pancreatography (ERP) with per-oral pancreatoscopy (POP) and intraductal lithotripsy and extracorporeal shock wave lithotripsy (ESWL) are feasible options to attempt ductal stone clearance. This study aims to compare POP-guided lithotripsy with ESWL in the management of refractory symptomatic main pancreatic duct stones. This is an open-label, multi-center, parallel, randomized clinical trial. Patients with chronic pancreatitis and main pancreatic duct stones ≥5 mm who fail standard ERP methods for stone removal will be eligible for this study. In total, 150 subjects will be randomized 1:1 to either ESWL or POP. A maximum of 4 sessions of either ESWL or POP will be allowed in each arm, with crossover permitted thereafter. The primary outcome is complete stone clearance and secondary outcomes include quality of life, pain scores, number of interventions, and daily opiate requirements. This study aims to answer the question of which lithotripsy method is superior in removing refractory pancreatic duct stones while addressing the effects of lithotripsy on quality of life and pain in patients with chronic calcific pancreatitis (ClinicalTrials.gov NCT04115826).
Sections du résumé
BACKGROUNDS/OBJECTIVES
UNASSIGNED
Patients with chronic pancreatitis may develop pancreatic duct stones that can obstruct outflow leading to ductal hypertension and pain. Both endoscopic retrograde pancreatography (ERP) with per-oral pancreatoscopy (POP) and intraductal lithotripsy and extracorporeal shock wave lithotripsy (ESWL) are feasible options to attempt ductal stone clearance. This study aims to compare POP-guided lithotripsy with ESWL in the management of refractory symptomatic main pancreatic duct stones.
METHODS
METHODS
This is an open-label, multi-center, parallel, randomized clinical trial. Patients with chronic pancreatitis and main pancreatic duct stones ≥5 mm who fail standard ERP methods for stone removal will be eligible for this study. In total, 150 subjects will be randomized 1:1 to either ESWL or POP. A maximum of 4 sessions of either ESWL or POP will be allowed in each arm, with crossover permitted thereafter. The primary outcome is complete stone clearance and secondary outcomes include quality of life, pain scores, number of interventions, and daily opiate requirements.
CONCLUSIONS
CONCLUSIONS
This study aims to answer the question of which lithotripsy method is superior in removing refractory pancreatic duct stones while addressing the effects of lithotripsy on quality of life and pain in patients with chronic calcific pancreatitis (ClinicalTrials.gov NCT04115826).
Identifiants
pubmed: 36273991
pii: S1424-3903(22)00749-9
doi: 10.1016/j.pan.2022.09.245
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04115826']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1120-1125Informations de copyright
Copyright © 2022 IAP and EPC. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Raj J Shah is an advisory board member and consultant for Boston Scientific and consultant for Olympus and Cook Medical. Michel Kahaleh is a Consultant for Boston Scientific, Concordia Laboratories, AbbVie, and ERBE and has received grant support from Boston Scientific, Apollo Endosurgery, Cook Endoscopy, ASPIRE Bariatrics, NinePoint Medical, Olympus, Merit Medical, and Interscope Med. All other authors report no conflicts of interest.