Pancreatic PseudocystNCT03002051
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
A study testing EUS-guided drainage in people with Pancreatic Pseudocyst and Pancreatic Necrosis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Pseudocyst, Pancreatic Necrosis, Biliary Obstruction
- What is being tested?
- EUS-guided drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to May 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
- The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
- Target lesion that is accessible through the transenteric approach
- The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
- The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
- The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.
Who cannot join
- Patient presenting with any of the following will not be included in the study.
- Inaccessible to EUS-guided approach
- Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet conunt < 60,000/mm3
- Patients with Disseminated Intravascular Coagulation syndrome(DIC)
- Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
- Patients with other serious disease or medical condition
- Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
- Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB
Read the detailed description
Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS
- Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
- Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
- Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
- Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
- Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)
Outcome paramaters include technical and clinical success, adverse events.
- Being tested
- EUS-guided drainage
- Medical subject headings
- Pancreatic Pseudocyst, Pancreatitis, Acute Necrotizing, Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided drainageDevice
- Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.
- EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.
- After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).
- After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.
- After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| EUS guided drainage | Experimental | Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent Receives: Device: EUS-guided drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success for pancreatic fluid collections
① Clinical success of pancreatic fluid collections
- Peudocyst: resolution more than 50% in the initial size of cyst.
- Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
Measured: 8 hrs
Clinical success for acute cholecystitis
- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
Measured: 8hrs
Clinical success for obstructive jaundice
- A decrease in total bilirubin to < 50 % of the pre-stenting value within 2 weeks.
Measured: 2 weeks
Secondary outcomes (2)
Techincal success
- Satisfactory access, placement of stent and drainage.
Measured: 1 day
Adverse events
- Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.
- Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.
- Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.
- Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018
- Study completionMay 2019
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Soonchunhyang University School of Medicine
- Responsible party
- Principal investigator, Anthony Teoh, Chinese University of Hong Kong
- Investigators
- Anthony Teoh, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002051
- Sponsor's protocol ID
- SPAXUS version 3.0
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Teoh AYB, Kongkam P, Bapaye A, Ratanachu T, Reknimitr R, Lakthakia S, Chan SM, Gadhikar HP, Korrapati SK, Lee YN, Medarapalem J, Ridtitid W, Moon JH. Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial. Dig Endosc. 2021 Nov;33(7):1139-1145. doi: 10.1111/den.13911. Epub 2021 Jan 11.
PubMed 33284467
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03002051
- Acronym / sponsor ID
- SPAXUS version 3.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Soonchunhyang University School of Medicine
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 Dec 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.
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB
Detailed description
Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS
- Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
- Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
- Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
- Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
- Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)
Outcome paramaters include technical and clinical success, adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS guided drainage | Experimental | Device: EUS-guided drainagePatients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
- The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
- Target lesion that is accessible through the transenteric approach
- The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
Key exclusion criteria (8 listed)
- Patient presenting with any of the following will not be included in the study.
- Inaccessible to EUS-guided approach
- Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet conunt < 60,000/mm3
- Patients with Disseminated Intravascular Coagulation syndrome(DIC)
- Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
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 drainage* Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage. * EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen. * After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm). * After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen. * After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance. | Device | EUS guided drainage |
Primary outcome
Clinical success for pancreatic fluid collections
Time frame: 8 hrs
① Clinical success of pancreatic fluid collections * Peudocyst: resolution more than 50% in the initial size of cyst. * Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
Clinical success for acute cholecystitis
Time frame: 8hrs
- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
Clinical success for obstructive jaundice
Time frame: 2 weeks
- A decrease in total bilirubin to < 50 % of the pre-stenting value within 2 weeks.
2 secondary outcomes
Techincal success
Time frame: 1 day
Adverse events
Time frame: 30 day
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 13 Dec 2019.
- Derived from this study: PubMed 33284467Teoh AYB, Kongkam P, Bapaye A, Ratanachu T, Reknimitr R, Lakthakia S, Chan SM, Gadhikar HP, Korrapati SK, Lee YN, Medarapalem J, Ridtitid W, Moon JH. Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial. Dig Endosc. 2021 Nov;33(7):1139-1145. doi: 10.1111/den.13911. Epub 2021 Jan 11.
- 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.
Anthony Teoh principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided drainage in people with Pancreatic Pseudocyst and Pancreatic Necrosis, run by Chinese University of Hong Kong 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 7 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: finished, as of the sponsor's last update on 13 Dec 2019. 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.
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?
Clinical success for pancreatic fluid collections (time frame: 8 hrs). The study lists 3 primary outcomes in all. 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 NCT03002051, 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 13 Dec 2019; AzTrials last refreshed its copy on 4 Nov 2026.