Pancreatic PseudocystNCT03027895
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
A study testing Lumen-apposing metal stent (LAMS) and Double pigtail plastic stent (DPPS) 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 double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON. 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?
- Lumen-apposing metal stent (LAMS) and Double pigtail plastic stent (DPPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Sep 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 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
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
Read the detailed description
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.
- Conditions
- Pancreatic Pseudocyst
- Being tested
- Lumen-apposing metal stent (LAMS), Double pigtail plastic stent (DPPS)
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumen-apposing metal stent (LAMS)Device
Endoscopic Ultrasound-guided Drainage of WON with LAMS
Double pigtail plastic stent (DPPS)Device
Endoscopic Ultrasound-guided Drainage of WON with DPPS
| Study group | Role | What they receive |
|---|---|---|
| Lumen-apposing metal stent(LAMS) | Experimental | Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS Receives: Device: Lumen-apposing metal stent (LAMS) |
| Double pigtail plastic stent(DPPS) | Active comparator | Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS Receives: Device: Double pigtail plastic stent (DPPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
Measured: uo to 1 months
Secondary outcomes (3)
adverse event
any adverse event occured after stent inserted
Measured: up to 2months/ stent remove
recurrence rate
After the clinical success, imaging examination show cyst again and accompanied by symptoms
Measured: up to 12 months
technical success
Stent placed through the wall bracket and pancreatic pseudocyst successfully
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 256 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
- NCT03027895
- Sponsor's protocol ID
- 2017010302
- Status last verified
- Mar 2018
- First submitted
- 14 Jan 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.
PubMed 30305160
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
- ClinicalTrials.gov ID
- NCT03027895
- Acronym / sponsor ID
- 2017010302
- Conditions
- Pancreatic Pseudocyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Yiqi DuUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 23 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 double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
Detailed description
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumen-apposing metal stent(LAMS) | Experimental | Device: Lumen-apposing metal stent (LAMS)Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS |
| Double pigtail plastic stent(DPPS) | Active comparator | Device: Double pigtail plastic stent (DPPS)Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS |
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 |
|---|---|---|
| Lumen-apposing metal stent (LAMS)Endoscopic Ultrasound-guided Drainage of WON with LAMS | Device | Lumen-apposing metal stent(LAMS) |
| Double pigtail plastic stent (DPPS)Endoscopic Ultrasound-guided Drainage of WON with DPPS | Device | Double pigtail plastic stent(DPPS) |
Primary outcome
clinical success
Time frame: uo to 1 months
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
3 secondary outcomes
adverse event
Time frame: up to 2months/ stent remove
recurrence rate
Time frame: up to 12 months
technical success
Time frame: up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 30305160Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.
- 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 Lumen-apposing metal stent (LAMS) and Double pigtail plastic stent (DPPS) 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 30 Mar 2018. 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?
clinical success (time frame: uo to 1 months). 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 NCT03027895, which also lists 1 linked publication.
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 30 Mar 2018.