Pancreatic PseudocystPhase 4NCT01585662
Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents
A Phase 4 study testing EUS-guided pancreatic pseudocyst drainage in people with Pancreatic Pseudocyst, run by Xiaoyin Zhang at 1 site in China.
Trial summary
EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to place several stents to drain the content of cyst into GI tract. In the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Pseudocyst
- What is being tested?
- EUS-guided pancreatic pseudocyst drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2014
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with ages from 18-80 years old.
- The pseudocysts were formed more than 3 months.
- The size of pseudocyst is more than 5 cm.
- The patient has the symptoms related with the pseudocyst.
- The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image.
- The consent form has been signed.
Who cannot join
- The patient can't accept the endoscopic procedure.
- The patient has blood coagulation dysfunction.
- The patient has mental disorders.
- The patient has mild or severe cardiorespiratory insufficiency.
- The patient has hypertension and can't be controlled to safe level.
- Diabetics whose blood sugar level can't be controlled to safe level.
Show all 9Show fewer
- Patients with alcohol dependence
- Pregnant and lactating women.
- The patients the investigator don't think suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Institute of digestive diseases
Xian City, Shanxi, 710032
Xiaoyin Zhang, MD,PhD, 86-29-84771540, zhangxy@fmmu.edu.cn
Xin Wang, MD,PhD, 86-29-84771516, wangx@fmmu.edu.cn
About this study
Official title: Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage
EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to place several stents to drain the content of cyst into GI tract. In the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified naso-pancreatic tube drainage method were found recurrent with a follow up period from 3 months-34 months. So, the investigators designed this prospective random comparing study to confirm the result.
- Conditions
- Pancreatic Pseudocyst
- Being tested
- EUS-guided pancreatic pseudocyst drainage
- Keywords
- EUS, pancreatic pseudocyst, 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.
EUS-guided pancreatic pseudocyst drainageProcedure or surgery
Also called Naso-pancreatic drainage tube:8 Fren,made by Cook Company, Two pig tails- stents:5cm long,made by Cook Company
EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.
| Study group | Role | What they receive |
|---|---|---|
| Naso-pancreatic tube | Experimental | The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method. Receives: Procedure: EUS-guided pancreatic pseudocyst drainage |
| Stents | Experimental | The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst. Receives: Procedure: EUS-guided pancreatic pseudocyst drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of pancreatic pseudocyst
Measured: 12 months
Secondary outcomes (1)
The complication rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoyin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoyin Zhang, Air Force Military Medical University, China
- Investigators
- Wu Kaichun, MD,PhD, Study chair, The forth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585662
- Sponsor's protocol ID
- 1111
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 2012
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Baron TH, Wiersema MJ. EUS-guided transesophageal pancreatic pseudocyst drainage. Gastrointest Endosc. 2000 Oct;52(4):545-9. doi: 10.1067/mge.2000.108928. No abstract available.
PubMed 11023579Seewald S, Thonke F, Ang TL, Omar S, Seitz U, Groth S, Zhong Y, Yekebas E, Izbicki J, Soehendra N. One-step, simultaneous double-wire technique facilitates pancreatic pseudocyst and abscess drainage (with videos). Gastrointest Endosc. 2006 Nov;64(5):805-8. doi: 10.1016/j.gie.2006.07.049.
PubMed 17055880Lopes CV, Pesenti C, Bories E, Caillol F, Giovannini M. Endoscopic-ultrasound-guided endoscopic transmural drainage of pancreatic pseudocysts and abscesses. Scand J Gastroenterol. 2007 Apr;42(4):524-9. doi: 10.1080/00365520601065093.
PubMed 17454865Barthet M, Lamblin G, Gasmi M, Vitton V, Desjeux A, Grimaud JC. Clinical usefulness of a treatment algorithm for pancreatic pseudocysts. Gastrointest Endosc. 2008 Feb;67(2):245-52. doi: 10.1016/j.gie.2007.06.014.
PubMed 18226686
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage
- ClinicalTrials.gov ID
- NCT01585662
- Acronym / sponsor ID
- 1111
- Conditions
- Pancreatic Pseudocyst
- Keywords
- EUS, pancreatic pseudocyst, drainage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiaoyin ZhangUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Apr 2012 (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.
EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to place several stents to drain the content of cyst into GI tract. In the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified naso-pancreatic tube drainage method were found recurrent with a follow up period from 3 months-34 months. So, the investigators designed this prospective random comparing study to confirm the result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naso-pancreatic tube | Experimental | Procedure: EUS-guided pancreatic pseudocyst drainageThe patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method. |
| Stents | Experimental | Procedure: EUS-guided pancreatic pseudocyst drainageThe patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults with ages from 18-80 years old.
- The pseudocysts were formed more than 3 months.
- The size of pseudocyst is more than 5 cm.
- The patient has the symptoms related with the pseudocyst.
- The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image.
Key exclusion criteria (9 listed)
- The patient can't accept the endoscopic procedure.
- The patient has blood coagulation dysfunction.
- The patient has mental disorders.
- The patient has mild or severe cardiorespiratory insufficiency.
- The patient has hypertension and can't be controlled to safe level.
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 |
|---|---|---|
| EUS-guided pancreatic pseudocyst drainageAlso: Naso-pancreatic drainage tube:8 Fren,made by Cook Company, Two pig tails- stents:5cm long,made by Cook CompanyEUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents. | Procedure or surgery | Naso-pancreatic tube, Stents |
Primary outcome
recurrence rate of pancreatic pseudocyst
Time frame: 12 months
1 secondary outcome
The complication rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
- Background: PubMed 11023579Baron TH, Wiersema MJ. EUS-guided transesophageal pancreatic pseudocyst drainage. Gastrointest Endosc. 2000 Oct;52(4):545-9. doi: 10.1067/mge.2000.108928. No abstract available.
- Background: PubMed 17055880Seewald S, Thonke F, Ang TL, Omar S, Seitz U, Groth S, Zhong Y, Yekebas E, Izbicki J, Soehendra N. One-step, simultaneous double-wire technique facilitates pancreatic pseudocyst and abscess drainage (with videos). Gastrointest Endosc. 2006 Nov;64(5):805-8. doi: 10.1016/j.gie.2006.07.049.
- Background: PubMed 17454865Lopes CV, Pesenti C, Bories E, Caillol F, Giovannini M. Endoscopic-ultrasound-guided endoscopic transmural drainage of pancreatic pseudocysts and abscesses. Scand J Gastroenterol. 2007 Apr;42(4):524-9. doi: 10.1080/00365520601065093.
- Background: PubMed 18226686Barthet M, Lamblin G, Gasmi M, Vitton V, Desjeux A, Grimaud JC. Clinical usefulness of a treatment algorithm for pancreatic pseudocysts. Gastrointest Endosc. 2008 Feb;67(2):245-52. doi: 10.1016/j.gie.2007.06.014.
Related trials for Pancreatic Pseudocyst
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
RecruitingObservational study
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Acute Pancreatitis, Pancreatic Pseudocyst
RecruitingObservational study
Management of Pancreatic Cystic Lesions Using Artificial Intelligence Based on EUS and Multimodal Data
Pancreatic Cystic Lesion, Mucinous Cystadenoma of Pancreas
Recruiting
Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
Pancreatic Pseudocyst
Not yet recruiting
WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts
Pancreatic Fluid Collection, Pancreatitis
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.
Wu Kaichun, MD,PhD study chair
The forth military medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EUS-guided pancreatic pseudocyst drainage in people with Pancreatic Pseudocyst, run by Xiaoyin Zhang at 1 site in China.
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 9 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 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xiaoyin Zhang, MD,PhD (86-29-84771540, zhangxy@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of pancreatic pseudocyst (time frame: 12 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 NCT01585662, which also lists 4 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 26 Apr 2012.