Pancreas PseudocystNCT06280248
EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection
A study testing Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst in people with Pancreas Pseudocyst, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Pseudocyst
- What is being tested?
- Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic sterile PFCs; symptoms include persistent abdominal pain, ileus, and gastric outlet obstruction with or without fever.
- Proven or suspected infected PFCs with or without the presence of necrosis.
- Patients with pancreatic pseudocyst that unresolved for at least 6 weeks after the last episode of pancreatitis and making compression on surrounding organs such as common bile duct (CBD), portal vein (PV).
Who cannot join
- Patient refusal.
- Patients with major comorbidities being unfit for general anesthesia.
- Patients with moderate to marked ascites.
- Patients with bleeding tendencies and impaired coagulation profile.
- Patients with proven or suspected malignant pancreatic neoplasms.
About this study
Official title: Study of Different Modalities of Endoscopic Ultrasound (EUS)-Guided Post-pancreatitis Pancreatic Fluid Collection Drainage
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.
Read the 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).
- 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.
- Conditions
- Pancreas Pseudocyst
- Being tested
- Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocystProcedure or surgery
The technical success rates, clinical success rates, and potential complications of the different endoscopic ultrasound-guided techniques for the best drainage of pancreatic fluid collections (PFCs) as regard type, caliber, and number of plastic stents and the ideal timing for stent removal will be assessed.
Also compare early vs. late intervention for complete endoscopic necrosectomy of walled off pancreatic necrosis (WOPN ) as regard to technical success rates, clinical success rates, potential complications, and the number of sessions needed will be done.
In order to evaluate total resolution or a reduction in cyst diameters with clinically significant improvement in symptoms, patients will be monitored for one month and six months following the insertion of the stent.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst | Other | Not described Receives: Procedure: Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs)
- Achievement of complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs) with clinical symptomatic improvement after 1 month and 6 months of stent placement using different EUS PFCs drainage techniques.
- Compare the technical and clinical success rates and potential complications of the different techniques of EUS guided pancreatic fluid collections (PFCs) drainage.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas PseudocystStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Abodief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280248
- Sponsor's protocol ID
- EUS in pancreatic fluid
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Different Modalities of Endoscopic Ultrasound (EUS)-Guided Post-pancreatitis Pancreatic Fluid Collection Drainage
- ClinicalTrials.gov ID
- NCT06280248
- Acronym / sponsor ID
- EUS in pancreatic fluid
- Conditions
- Pancreas Pseudocyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst | Other | Procedure: Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic sterile PFCs; symptoms include persistent abdominal pain, ileus, and gastric outlet obstruction with or without fever.
- Proven or suspected infected PFCs with or without the presence of necrosis.
- Patients with pancreatic pseudocyst that unresolved for at least 6 weeks after the last episode of pancreatitis and making compression on surrounding organs such as common bile duct (CBD), portal vein (PV).
Key exclusion criteria (5 listed)
- Patient refusal.
- Patients with major comorbidities being unfit for general anesthesia.
- Patients with moderate to marked ascites.
- Patients with bleeding tendencies and impaired coagulation profile.
- Patients with proven or suspected malignant pancreatic neoplasms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocystThe technical success rates, clinical success rates, and potential complications of the different endoscopic ultrasound-guided techniques for the best drainage of pancreatic fluid collections (PFCs) as regard type, caliber, and number of plastic stents and the ideal timing for stent removal will be assessed. Also compare early vs. late intervention for complete endoscopic necrosectomy of walled off pancreatic necrosis (WOPN ) as regard to technical success rates, clinical success rates, potential complications, and the number of sessions needed will be done. In order to evaluate total resolution or a reduction in cyst diameters with clinically significant improvement in symptoms, patients will be monitored for one month and six months following the insertion of the stent. | Procedure or surgery | Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst |
Primary outcome
Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs)
Time frame: 2 year
* Achievement of complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs) with clinical symptomatic improvement after 1 month and 6 months of stent placement using different EUS PFCs drainage techniques. * Compare the technical and clinical success rates and potential complications of the different techniques of EUS guided pancreatic fluid collections (PFCs) drainage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Pancreas Pseudocyst
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
RecruitingObservational study
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Acute Pancreatitis, Pancreatic Pseudocyst
RecruitingObservational study
Management of Pancreatic Cystic Lesions Using Artificial Intelligence Based on EUS and Multimodal Data
Pancreatic Cystic Lesion, Mucinous Cystadenoma of Pancreas
Recruiting
Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
Pancreatic Pseudocyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst in people with Pancreas Pseudocyst, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.