Pseudocyst PancreasNCT04494282
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
A study testing Endoscopic retrograde pancreatography in people with Pseudocyst Pancreas and Pancreatic Duct Disorder, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial summary
Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pseudocyst Pancreas, Pancreatic Duct Disorder
- What is being tested?
- Endoscopic retrograde pancreatography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic pseudocyst that fulfilled the Atlanta Classification
- Symptomatic pancreatic pseudocyst
- Informed consent obtained
Who cannot join
- Patient unwilling to participate
- Absence of duration time of the pancreatography procedure in the record
- Absence of the number of weeks between the drainage and the pancreatography
About this study
Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.
Read the detailed description
METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent will be explained and signed. In those patients who ERP fails, a second attempt will be performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance cholangiopancreatography will be performed (Group 2).
- Conditions
- Pseudocyst Pancreas, Pancreatic Duct Disorder
- Being tested
- Endoscopic retrograde pancreatography
- Keywords
- 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 retrograde pancreatographyProcedure or surgery
Endoscopic cannulation of main pancreatic duct
| Study group | Role | What they receive |
|---|---|---|
| Same day | Active comparator | The ERP will be performed the same day of the endoscopic drainage of PP Receives: Procedure: Endoscopic retrograde pancreatography |
| Other day | Active comparator | The ERP will be performed 6 weeks after the endoscopic drainage of PP. Receives: Procedure: Endoscopic retrograde pancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts
Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study startAug 2015
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudocyst PancreasStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Saúl, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494282
- Sponsor's protocol ID
- INCMNSZ
- Status last verified
- Mar 2024
- First submitted
- 28 Jul 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
- ClinicalTrials.gov ID
- NCT04494282
- Acronym / sponsor ID
- INCMNSZ
- Conditions
- Pseudocyst Pancreas, Pancreatic Duct Disorder
- Keywords
- Pancreatic Pseudocyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 31 Jul 2020 (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.
Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.
Detailed description
METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent will be explained and signed. In those patients who ERP fails, a second attempt will be performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance cholangiopancreatography will be performed (Group 2).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Random control trial
| Arm | Type | Receives |
|---|---|---|
| Same day | Active comparator | Procedure: Endoscopic retrograde pancreatographyThe ERP will be performed the same day of the endoscopic drainage of PP |
| Other day | Active comparator | Procedure: Endoscopic retrograde pancreatographyThe ERP will be performed 6 weeks after the endoscopic drainage of PP. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pancreatic pseudocyst that fulfilled the Atlanta Classification
- Symptomatic pancreatic pseudocyst
- Informed consent obtained
Key exclusion criteria (3 listed)
- Patient unwilling to participate
- Absence of duration time of the pancreatography procedure in the record
- Absence of the number of weeks between the drainage and the pancreatography
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 retrograde pancreatographyEndoscopic cannulation of main pancreatic duct | Procedure or surgery | Other day, Same day |
Primary outcome
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts
Time frame: 6 weeks
Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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 retrograde pancreatography in people with Pseudocyst Pancreas and Pancreatic Duct Disorder, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
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 3 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: finished, as of the sponsor's last update on 6 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts (time frame: 6 weeks). 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 6 Mar 2024.