Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280248
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Brief Title:
EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Study of Different Modalities of Endoscopic Ultrasound EUS-Guided Post-pancreatitis Pancreatic Fluid Collection Drainage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice Lin et al 2014 The timing of necrosectomy in WOPN drainage continues to be debated To date no comparative studies have been conducted to investigate the ideal timing for stent removal Thus the aim of our study is to
Assess the technical success rates clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type caliber and number of plastic stents and ideal timing for stent removal
Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates clinical success rates potential complications and number of sessions needed
Assess the technical success rates clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type caliber and number of plastic stents and ideal timing for stent removal
Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates clinical success rates potential complications and number of sessions needed
Detailed Description:
Acute pancreatitis AP accounts for over 50 of all hospital admissions for pancreatic disease and still represents one of the most unpredictable diseases of the digestive system NICE guideline 2018 Therefore AP can be linked to a number of systemic or local problems in its most severe form it can result in multiple organ failure and even death Rana et al 2015
Pancreatic fluid collections PFCs are a common complication of AP with a reported incidence of 43 Cui et al 2014 When there is pancreatic damage such as AP pancreatic trauma postsurgery posttransplant or occlusion of the pancreatic duct PD PFCs develop The management of PFCs must be guided by the classification of these entities according to their acuity and the presence or absence of necrosis
Surgical drainage has been the standard of care for PFCs The paradigm has however changed in favor of methods requiring endoscopic intervention and minimally invasive drainage due to recent advancements in endoscopic tools and techniques Cui et al 2014
The Atlanta criteria refer to the initial global agreement on PFC classification that was created in 1993 PFCs were categorized as acute forming within 4 weeks of pancreatitis onset or chronic forming after 4 weeks of pancreatitis onset based on the original Atlanta criteria Pancreatic necrosis pancreatic pseudocysts PPs or pancreatic abscesses were the three further subtypes of chronic PFCs Bradley et al 1993
Recent advances in pathophysiology and diagnostic tools warranted a revision to these criteria The most important distinction to arise from the new classification system known as the revised Atlanta criteria Banks et al 2013 is the delineation between collections containing only fluid and collections containing necrotic tissue with or without accompanying fluid
The criteria for acute versus chronic PFCs is preserved but new additions have been made based on the presence of necrosis Acute collections are divided into acute peripancreatic fluid collections and acute necrotic collections Chronic collections are divided into PPs and walled-off pancreatic necroses WOPNs These distinctions have helped guide the development of treatment strategies tailored to the acuity and contents of a given collection Banks et al 2013
The original Atlanta criteria recommended drainage for PFCs based on the size of the collection as well as the presence of symptoms including abdominal pain gastrointestinal GI or biliary obstruction vascular compression or infection With recent advances in diagnostic tools and interventional techniques indications for the drainage of PFCs have been revised to emphasize the presence of symptoms or infected collection Trikudanathan et al 2019
1 Symptomatic sterile collections with or without the presence of necrosis symptoms include persistent abdominal pain ileus and gastric outlet obstruction with or without fever
2 Proven or suspected infected PFCs with or without the presence of necrosis Asymptomatic sterile necrotic collections and asymptomatic WOPN are not recommended for drainage as they may undergo spontaneous resolution given time Freeman et al 2012
The reason is that among asymptomatic necrosis the content is liquefied in 28-35 of cases and the size decreases especially in extra-pancreatic WON or WON without a disconnected pancreatic duct without the need for further necrosectomy Pawar et al 2021
According to a recent meta-analysis Nakai et al 2023 early interventions before 4 weeks for necrotizing pancreatitis were associated with higher mortality the same rate of adverse events and clinical success compared to delayed interventions however another meta-analysis reported similar outcomes for early or delayed interventions but a longer hospital stay for early interventions Ramai et al 2023
As EUS can precisely quantify the distance between the GI lumen and the pseudocyst and use Doppler US to define a safe nonvascular window for draining it is the recommended method for evaluating PFCs Giovannini et al 2007 Similarly the type of stent that is selected for drainage can also be directly impacted by the sort of fluid that EUS detects
Pancreatic fluid collections PFCs are a common complication of AP with a reported incidence of 43 Cui et al 2014 When there is pancreatic damage such as AP pancreatic trauma postsurgery posttransplant or occlusion of the pancreatic duct PD PFCs develop The management of PFCs must be guided by the classification of these entities according to their acuity and the presence or absence of necrosis
Surgical drainage has been the standard of care for PFCs The paradigm has however changed in favor of methods requiring endoscopic intervention and minimally invasive drainage due to recent advancements in endoscopic tools and techniques Cui et al 2014
The Atlanta criteria refer to the initial global agreement on PFC classification that was created in 1993 PFCs were categorized as acute forming within 4 weeks of pancreatitis onset or chronic forming after 4 weeks of pancreatitis onset based on the original Atlanta criteria Pancreatic necrosis pancreatic pseudocysts PPs or pancreatic abscesses were the three further subtypes of chronic PFCs Bradley et al 1993
Recent advances in pathophysiology and diagnostic tools warranted a revision to these criteria The most important distinction to arise from the new classification system known as the revised Atlanta criteria Banks et al 2013 is the delineation between collections containing only fluid and collections containing necrotic tissue with or without accompanying fluid
The criteria for acute versus chronic PFCs is preserved but new additions have been made based on the presence of necrosis Acute collections are divided into acute peripancreatic fluid collections and acute necrotic collections Chronic collections are divided into PPs and walled-off pancreatic necroses WOPNs These distinctions have helped guide the development of treatment strategies tailored to the acuity and contents of a given collection Banks et al 2013
The original Atlanta criteria recommended drainage for PFCs based on the size of the collection as well as the presence of symptoms including abdominal pain gastrointestinal GI or biliary obstruction vascular compression or infection With recent advances in diagnostic tools and interventional techniques indications for the drainage of PFCs have been revised to emphasize the presence of symptoms or infected collection Trikudanathan et al 2019
1 Symptomatic sterile collections with or without the presence of necrosis symptoms include persistent abdominal pain ileus and gastric outlet obstruction with or without fever
2 Proven or suspected infected PFCs with or without the presence of necrosis Asymptomatic sterile necrotic collections and asymptomatic WOPN are not recommended for drainage as they may undergo spontaneous resolution given time Freeman et al 2012
The reason is that among asymptomatic necrosis the content is liquefied in 28-35 of cases and the size decreases especially in extra-pancreatic WON or WON without a disconnected pancreatic duct without the need for further necrosectomy Pawar et al 2021
According to a recent meta-analysis Nakai et al 2023 early interventions before 4 weeks for necrotizing pancreatitis were associated with higher mortality the same rate of adverse events and clinical success compared to delayed interventions however another meta-analysis reported similar outcomes for early or delayed interventions but a longer hospital stay for early interventions Ramai et al 2023
As EUS can precisely quantify the distance between the GI lumen and the pseudocyst and use Doppler US to define a safe nonvascular window for draining it is the recommended method for evaluating PFCs Giovannini et al 2007 Similarly the type of stent that is selected for drainage can also be directly impacted by the sort of fluid that EUS detects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None