PancreatitisNCT02648815
Management of Pancreatitis: the Role of Supportive and Drainage Treatment
A study testing Percutaneous catheter drainage and Abdominal paracentesis evacuation in people with Pancreatitis, run by University Clinical Center Tuzla.
Trial summary
This study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Percutaneous catheter drainage and Abdominal paracentesis evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2017
- 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
- fluid collections within two weeks of disease onset;
- single- or multi-organ failure;
- CTSI > = 7 (initial CT performed within 7 days after the onset of disease.); and (4) acute physiology and chronic health evaluation (APACHE) II score > = 8.
Who cannot join
- patients without APD interventions;
- patients who underwent necrosectomy directly after APD without PCD as a bridge therapy;
- previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis;
- previous exploratory laparotomy for acute abdomen and intraoperative diagnosis of AP.
About this study
Official title: Management of Moderate and Severe Forms of Acute Pancreatitis
This study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. Although no universally accepted treatment algorithm exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage, followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to produce superior outcomes to traditional open necrosectomy and may be considered as the reference standard intervention for this disorder.
Read the detailed description
Despite overall reduced mortality in the last decade, MSAP and SAP are devastating diseases associated with mortality ranging from less than 10% to as high as 85%, according to various studies. The management of SAP is complicated because of the limited understanding of the pathogenesis and multi-causality of the disease, uncertainties in outcome prediction and few effective treatment modalities. Generally, sterile necrosis can be managed conservatively in the majority of cases with a low mortality rate (12%). However, infection of pancreatic necrosis can be observed in 25%-70% of patients with necrotizing disease; it is generally accepted that the infected non-vital tissue should be removed to control the sepsis. Laparotomy and immediate debridement of the infected necrotic tissue have been the gold standard treatment for decades. However, several reports have shown that early surgical intervention for pancreatic necrosis could result in a worse prognosis compared to cases where surgery is delayed or avoided. Therefore, several groups worldwide have developed new, minimally invasive approaches for managing infected necrotizing pancreatitis. The applicability of these techniques depends on the availability of specialized expertise and a multidisciplinary team dedicated to the management of SAP and its complications.
- Conditions
- Pancreatitis
- Being tested
- Percutaneous catheter drainage, Abdominal paracentesis evacuation
- Keywords
- Necrotizing pancreatitis, Sepsis, Infection, Drainage
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing, Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous catheter drainageProcedure or surgery
Depending on the operator experience, tandem trocar technique or Seldinger technique can be used. If the Seldinger technique is used, then the catheter tract should be sequentially dilated over a guidewire. Access routes that avoid crossing the bowel and other intervening organs, or major mesenteric, peripancreatic, or retroperitoneal blood vessels are selected to minimize the risk of bacterial contamination and hemorrhage. Successful percutaneous treatment of necrotic collections of the pancreas depends on several important factors. Catheters often need to remain in place for several weeks and sometimes months; hence, close follow-up is required.
Abdominal paracentesis evacuationProcedure or surgery
Evacuation of peritoneal ascitic fluid using percutaneous catheters
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous catheter drainage group | Active comparator | Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis Receives: Procedure: Percutaneous catheter drainage |
| Abdominal paracentesis evacuation group | Active comparator | Abdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis Receives: Procedure: Abdominal paracentesis evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants converted to more aggressive treatment
Measured: An average of 1 year
Secondary outcomes (3)
Proportion of patients requiring PCD after initial APD
Measured: An average of 1 year
Morbidity and mortality in patients requiring PCD
Measured: An average of 1 year
Number of PCD interventions required
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2010
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Center Tuzla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enver Zerem, University Clinical Center Tuzla
- Investigators
- Enver Zerem, MD.PhD, Principal investigator, University Clinical Center Tuzla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648815
- Sponsor's protocol ID
- UClinicalCenterTuzla
- Other IDs
- 04-09/2-93/15
- Status last verified
- Oct 2016
- First submitted
- 31 Dec 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zerem E. Treatment of severe acute pancreatitis and its complications. World J Gastroenterol. 2014 Oct 14;20(38):13879-92. doi: 10.3748/wjg.v20.i38.13879.
PubMed 25320523Zerem E, Imamovic G, Susic A, Haracic B. Step-up approach to infected necrotising pancreatitis: a 20-year experience of percutaneous drainage in a single centre. Dig Liver Dis. 2011 Jun;43(6):478-83. doi: 10.1016/j.dld.2011.02.020. Epub 2011 Apr 8.
PubMed 21478061Zerem E, Imamovic G, Omerovic S, Imsirovic B. Randomized controlled trial on sterile fluid collections management in acute pancreatitis: should they be removed? Surg Endosc. 2009 Dec;23(12):2770-7. doi: 10.1007/s00464-009-0487-2. Epub 2009 May 15.
PubMed 19444515
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Moderate and Severe Forms of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT02648815
- Acronym / sponsor ID
- UClinicalCenterTuzla
- Conditions
- Pancreatitis
- Keywords
- Necrotizing pancreatitis, Sepsis, Infection, Drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Clinical Center TuzlaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- 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.
This study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. Although no universally accepted treatment algorithm exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage, followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to produce superior outcomes to traditional open necrosectomy and may be considered as the reference standard intervention for this disorder.
Detailed description
Despite overall reduced mortality in the last decade, MSAP and SAP are devastating diseases associated with mortality ranging from less than 10% to as high as 85%, according to various studies. The management of SAP is complicated because of the limited understanding of the pathogenesis and multi-causality of the disease, uncertainties in outcome prediction and few effective treatment modalities. Generally, sterile necrosis can be managed conservatively in the majority of cases with a low mortality rate (12%). However, infection of pancreatic necrosis can be observed in 25%-70% of patients with necrotizing disease; it is generally accepted that the infected non-vital tissue should be removed to control the sepsis. Laparotomy and immediate debridement of the infected necrotic tissue have been the gold standard treatment for decades. However, several reports have shown that early surgical intervention for pancreatic necrosis could result in a worse prognosis compared to cases where surgery is delayed or avoided. Therefore, several groups worldwide have developed new, minimally invasive approaches for managing infected necrotizing pancreatitis. The applicability of these techniques depends on the availability of specialized expertise and a multidisciplinary team dedicated to the management of SAP and its complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous catheter drainage group | Active comparator | Procedure: Percutaneous catheter drainagePercutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis |
| Abdominal paracentesis evacuation group | Active comparator | Procedure: Abdominal paracentesis evacuationAbdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- fluid collections within two weeks of disease onset;
- single- or multi-organ failure;
- CTSI > = 7 (initial CT performed within 7 days after the onset of disease.); and (4) acute physiology and chronic health evaluation (APACHE) II score > = 8.
Key exclusion criteria (4 listed)
- patients without APD interventions;
- patients who underwent necrosectomy directly after APD without PCD as a bridge therapy;
- previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis;
- previous exploratory laparotomy for acute abdomen and intraoperative diagnosis of AP.
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 |
|---|---|---|
| Percutaneous catheter drainageDepending on the operator experience, tandem trocar technique or Seldinger technique can be used. If the Seldinger technique is used, then the catheter tract should be sequentially dilated over a guidewire. Access routes that avoid crossing the bowel and other intervening organs, or major mesenteric, peripancreatic, or retroperitoneal blood vessels are selected to minimize the risk of bacterial contamination and hemorrhage. Successful percutaneous treatment of necrotic collections of the pancreas depends on several important factors. Catheters often need to remain in place for several weeks and sometimes months; hence, close follow-up is required. | Procedure or surgery | Percutaneous catheter drainage group |
| Abdominal paracentesis evacuationEvacuation of peritoneal ascitic fluid using percutaneous catheters | Procedure or surgery | Abdominal paracentesis evacuation group |
Primary outcome
Number of participants converted to more aggressive treatment
Time frame: An average of 1 year
3 secondary outcomes
Proportion of patients requiring PCD after initial APD
Time frame: An average of 1 year
Morbidity and mortality in patients requiring PCD
Time frame: An average of 1 year
Number of PCD interventions required
Time frame: An average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Results publication: PubMed 25320523Zerem E. Treatment of severe acute pancreatitis and its complications. World J Gastroenterol. 2014 Oct 14;20(38):13879-92. doi: 10.3748/wjg.v20.i38.13879.
- Results publication: PubMed 21478061Zerem E, Imamovic G, Susic A, Haracic B. Step-up approach to infected necrotising pancreatitis: a 20-year experience of percutaneous drainage in a single centre. Dig Liver Dis. 2011 Jun;43(6):478-83. doi: 10.1016/j.dld.2011.02.020. Epub 2011 Apr 8.
- Results publication: PubMed 19444515Zerem E, Imamovic G, Omerovic S, Imsirovic B. Randomized controlled trial on sterile fluid collections management in acute pancreatitis: should they be removed? Surg Endosc. 2009 Dec;23(12):2770-7. doi: 10.1007/s00464-009-0487-2. Epub 2009 May 15.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
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.
Enver Zerem, MD.PhD principal investigator
University Clinical Center Tuzla
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous catheter drainage and Abdominal paracentesis evacuation in people with Pancreatitis, run by University Clinical Center Tuzla.
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 4 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 Oct 2016. 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?
Number of participants converted to more aggressive treatment (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648815, which also lists 3 linked publications.
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 Oct 2016.