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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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).

  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.

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 groups in NCT06280248
Study groupRoleWhat they receive
Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocystOtherNot 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.

  1. 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.

  1. First posted28 Feb 2024
  2. Study startMar 2024 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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)
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

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.

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