Pancreatic PseudocystNCT03022110
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
A study testing Endoscopic Ultrasound-guided Drainage in people with Pancreatic Pseudocyst, run by Yiqi Du.
Trial summary
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Pseudocyst
- What is being tested?
- Endoscopic Ultrasound-guided Drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with ages from 18-80 years old
- Subject with pancreatic pseudocysts confirmed by CT
- Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
- The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
- Subject has the symptoms related with the pseudocyst
- The consent form has been signed
Who cannot join
- Subject is younger than 18 years or older than 80 years
- Pancreatic pseudocyst communicate with the main pancreatic duct
- Subject can't accept the endoscopic procedure
- Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
- The distance between gastric and the wall of the pseudocyst is more than 1 cm
- Subject with 2 or more than 2 cysts
- Subject has blood coagulation dysfunction
- Pregnant or subject has mental disorders
About this study
Official title: Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.
Read the detailed description
Inclusion criteria
- Subject with ages from 18-80 years old
- Subject with pancreatic pseudocysts confirmed by CT
- Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
- The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
- Subject has the symptoms related with the pseudocyst
- The consent form has been signed
Exclusion criteria
- Subject is younger than 18 years or older than 80 years
- Pancreatic pseudocyst communicate with the main pancreatic duct
- Subject can't accept the endoscopic procedure
- Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
- The distance between gastric and the wall of the pseudocyst is more than 1 cm
- Subject with 2 or more than 2 cysts
- Subject has blood coagulation dysfunction
- Pregnant or subject has mental disorders
- Conditions
- Pancreatic Pseudocyst
- Being tested
- Endoscopic Ultrasound-guided Drainage
- 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 DrainageDevice
Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| plastic stent | Active comparator | Endoscopic Ultrasound-guided Drainage with plastic stent Receives: Device: Endoscopic Ultrasound-guided Drainage |
| lumen-apposing metal stent (LAMS) | Experimental | Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent Receives: Device: Endoscopic Ultrasound-guided Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyst recurrence rate
Measured: up to 12 months
Secondary outcomes (3)
Technical success rate
Measured: up to 48 hours
Clinical success rate
Measured: up to 12 months
Complication rate
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic PseudocystStudies 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
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yiqi Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yiqi Du, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022110
- Sponsor's protocol ID
- 2017010301
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03022110
- Acronym / sponsor ID
- 2017010301
- Conditions
- Pancreatic Pseudocyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Yiqi DuUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jan 2017 (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.
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.
Detailed description
Inclusion criteria
- Subject with ages from 18-80 years old
- Subject with pancreatic pseudocysts confirmed by CT
- Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
- The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
- Subject has the symptoms related with the pseudocyst
- The consent form has been signed
Exclusion criteria
- Subject is younger than 18 years or older than 80 years
- Pancreatic pseudocyst communicate with the main pancreatic duct
- Subject can't accept the endoscopic procedure
- Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
- The distance between gastric and the wall of the pseudocyst is more than 1 cm
- Subject with 2 or more than 2 cysts
- Subject has blood coagulation dysfunction
- Pregnant or subject has mental disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plastic stent | Active comparator | Device: Endoscopic Ultrasound-guided DrainageEndoscopic Ultrasound-guided Drainage with plastic stent |
| lumen-apposing metal stent (LAMS) | Experimental | Device: Endoscopic Ultrasound-guided DrainageEndoscopic Ultrasound-guided Drainage with lumen-apposing metal stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject with ages from 18-80 years old
- Subject with pancreatic pseudocysts confirmed by CT
- Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
- The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
- Subject has the symptoms related with the pseudocyst
Key exclusion criteria (8 listed)
- Subject is younger than 18 years or older than 80 years
- Pancreatic pseudocyst communicate with the main pancreatic duct
- Subject can't accept the endoscopic procedure
- Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
- The distance between gastric and the wall of the pseudocyst is more than 1 cm
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 DrainagePancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound | Device | lumen-apposing metal stent (LAMS), plastic stent |
Primary outcome
Cyst recurrence rate
Time frame: up to 12 months
3 secondary outcomes
Technical success rate
Time frame: up to 48 hours
Clinical success rate
Time frame: up to 12 months
Complication rate
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Individual participant dataSharing planned: No
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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 Ultrasound-guided Drainage in people with Pancreatic Pseudocyst, run by Yiqi Du.
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 6 inclusion and 8 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 16 Jan 2017. 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?
Cyst recurrence rate (time frame: up to 12 months). 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 16 Jan 2017.