Pancreas NecrosisPROMETHEUSNCT03100578
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.
A study testing WOPN TRANSMURAL DRAINAGE: PLASTIC STENT and WOPN TRANSMURAL DRAINAGE: METALLIC STENT in people with Pancreas Necrosis and Pancreatic Collection, run by Hospital Universitari de Bellvitge at 8 sites in Spain.
Trial summary
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis. Spanish centers partners of the spanish society of digestive endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Necrosis, Pancreatic Collection
- What is being tested?
- WOPN TRANSMURAL DRAINAGE: PLASTIC STENT and WOPN TRANSMURAL DRAINAGE: METALLIC STENT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 8 sitesSpain
- Study dates
- 27 Jun 2017to 30 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Patient with indication (ASGE, Jacobson BC, GIE2005;) of pancreatic collection drainage type WALLED-OFF PANCREATIC NECROSIS * as a local complication of previous acute pancreatitis.
- Patient trained to understand and / or sign informed consent
- Patient who understands the type of study and will comply with all follow-up of complementary tests during its duration
Who cannot join
- Pregnancy or breastfeeding
- Severe coagulation disorder: INR> 1.5 not correctable with plasma and / or platelet administration <50,000 / mm3
- Asymptomatic patients, with no clinical indication of drainage, except for those with vascular involvement due to compression (eg stenosis, splenic vessels with collateral circulation, and risk of bleeding)
- Non-identification of solid content during the Endoscopic Ultrasound of the procedure
- No informed consent
- In the case of patients with mental retardation, without the ability to understand the nature and possible consequences of the study, except for the existence of a legal representative
- Patients unable to maintain posterior follow-up (lack of adherence)
- Situations that do not allow the practice of a high digestive endoscopy (eg, stenosis)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Arnau de Vilanova
Lleida, Barcelona, 25198
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital San Juan de Dios
Pamplona, Navarre, 31006
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Río Hortega
Valladolid, Valldolid, 47012
About this study
Official title: Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.
Spanish centers partners of the spanish society of digestive endoscopy.
- Conditions
- Pancreas Necrosis, Pancreatic Collection
- Being tested
- WOPN TRANSMURAL DRAINAGE: PLASTIC STENT, WOPN TRANSMURAL DRAINAGE: METALLIC STENT
- Keywords
- PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOPN TRANSMURAL DRAINAGE: PLASTIC STENTDevice
Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis:
The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels.
This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist.
Placement of a plastic double pigtail, 5-10 cm in length, diameters 7-8,5-10 Fr. Minimum one 10 Fr prosthesis.
Arm associated: PLASTIC STENT
WOPN TRANSMURAL DRAINAGE: METALLIC STENTDevice
Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis:
The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels.
This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist.
Placement of a metal self-expanding fully covered luminal apposition stent: 10, 15 or 20 mm diameter.
Arm associated: SELF EXPANDABLE METALLIC STENT
| Study group | Role | What they receive |
|---|---|---|
| PLASTIC STENT | Experimental | Endoscopic double pigtail plastic stent, with formal indication on pancreatic collection, according to the instruction forms of the manufacturer.
Interventions associated:
EUS-guided transmural drainage of pancretic collection: PLASTIC STENT. Receives: Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT |
| SELF EXPANDABLE METALLIC STENT | Active comparator | Lumen apposing metal stent with formal indicaction on pancreatic collection, according to the manufacturer instruction forms.
Interventions associated:
EUS-guided transmural drainage of pancretic collection: METALLIC STENT. Receives: Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
RADIOLOGICAL SUCCESS
Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.
Measured: 4 weeks
Secondary outcomes (5)
CLINICAL SUCCESS
Evaluate the long-term clinical success (4 months) (metallic vs. plastic) determined by the total resolution or <3cm of the WOPN, releated with clinical improvement.
Measured: 4 month
TECHNICAL ASPECTS
Evaluate the technical success, duration of the procedure and level of difficulty.
Measured: 1st day
INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]
Assess safety: complications (immediate, early and late)
Measured: 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
RECURRENCES
Evaluate recurrences
Measured: 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
COSTS ANALYSIS
Evaluate the costs between the two types of strategy
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start27 Jun 2017
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreas NecrosisStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Spanish Clinical Research Network - SCReN
- Responsible party
- Principal investigator, Joan B Gornals, Hospital Universitari de Bellvitge
- Investigators
- JOAN B GORNALS, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100578
- Sponsor's protocol ID
- PROMETHEUS
- Acronym
- PROMETHEUS
- Status last verified
- Nov 2021
- First submitted
- 29 Mar 2017
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gornals JB, Velasquez-Rodriguez JG, Bas-Cutrina F, Garcia Garcia De Paredes A, Esteban JM, Teran A, Gonzalez-Huix F, Perez-Miranda M, Guarner-Argente C, Vila JJ, Garcia-Sumalla A, Foruny JR, Fisac-Vazquez J, Moris M, Miquel-Salas I, De-la-Serna Higuera C, Murzi-Pulgar M, Sanchez-Yague A, Salord S, Ruiz-Osuna S, Busquets J, Sanllorente-Melenchon M, Videla S, Moreno R, Tebe-Cordomi C, Hereu P, Vazquez-Sequeiros E; Spanish Working Group on Pancreatic Collection Therapy. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial. Surg Endosc. 2024 Apr;38(4):2148-2159. doi: 10.1007/s00464-024-10699-w. Epub 2024 Mar 6.
PubMed 38448625Gornals JB, Perez-Miranda M, Vazquez-Sequeiros E, Vila J, Esteban JM, Gonzalez-Huix F, Guarner-Argente C, Sanchez-Yague A, Teran A, Bas-Cutrina F, De La Serna C, De Paredes AG, Ballester R, Velasquez-Rodriguez J, Salord S, Tebe C, Hereu P, Videla S; Spanish Working Group on Pancreatic Collection Therapy. Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol. Trials. 2019 Dec 30;20(1):791. doi: 10.1186/s13063-019-3988-x.
PubMed 31888751
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.
- ClinicalTrials.gov ID
- NCT03100578
- Acronym / sponsor ID
- PROMETHEUS / PROMETHEUS
- Conditions
- Pancreas Necrosis, Pancreatic Collection
- Keywords
- PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Spanish Clinical Research Network - SCReN
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 4 Apr 2017 (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.
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.
Spanish centers partners of the spanish society of digestive endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLASTIC STENT | Experimental | Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENTEndoscopic double pigtail plastic stent, with formal indication on pancreatic collection, according to the instruction forms of the manufacturer. Interventions associated: EUS-guided transmural drainage of pancretic collection: PLASTIC STENT. |
| SELF EXPANDABLE METALLIC STENT | Active comparator | Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENTLumen apposing metal stent with formal indicaction on pancreatic collection, according to the manufacturer instruction forms. Interventions associated: EUS-guided transmural drainage of pancretic collection: METALLIC STENT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years
- Patient with indication (ASGE, Jacobson BC, GIE2005;) of pancreatic collection drainage type WALLED-OFF PANCREATIC NECROSIS * as a local complication of previous acute pancreatitis.
- Patient trained to understand and / or sign informed consent
- Patient who understands the type of study and will comply with all follow-up of complementary tests during its duration
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- Severe coagulation disorder: INR> 1.5 not correctable with plasma and / or platelet administration <50,000 / mm3
- Asymptomatic patients, with no clinical indication of drainage, except for those with vascular involvement due to compression (eg stenosis, splenic vessels with collateral circulation, and risk of bleeding)
- Non-identification of solid content during the Endoscopic Ultrasound of the procedure
- No informed consent
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 |
|---|---|---|
| WOPN TRANSMURAL DRAINAGE: PLASTIC STENTEndoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis: The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels. This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist. Placement of a plastic double pigtail, 5-10 cm in length, diameters 7-8,5-10 Fr. Minimum one 10 Fr prosthesis. Arm associated: PLASTIC STENT | Device | PLASTIC STENT |
| WOPN TRANSMURAL DRAINAGE: METALLIC STENTEndoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis: The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels. This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist. Placement of a metal self-expanding fully covered luminal apposition stent: 10, 15 or 20 mm diameter. Arm associated: SELF EXPANDABLE METALLIC STENT | Device | SELF EXPANDABLE METALLIC STENT |
Primary outcome
RADIOLOGICAL SUCCESS
Time frame: 4 weeks
Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.
5 secondary outcomes
CLINICAL SUCCESS
Time frame: 4 month
TECHNICAL ASPECTS
Time frame: 1st day
INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]
Time frame: 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
RECURRENCES
Time frame: 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
COSTS ANALYSIS
Time frame: 12 month
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 10 Nov 2021.
- Derived from this study: PubMed 38448625Gornals JB, Velasquez-Rodriguez JG, Bas-Cutrina F, Garcia Garcia De Paredes A, Esteban JM, Teran A, Gonzalez-Huix F, Perez-Miranda M, Guarner-Argente C, Vila JJ, Garcia-Sumalla A, Foruny JR, Fisac-Vazquez J, Moris M, Miquel-Salas I, De-la-Serna Higuera C, Murzi-Pulgar M, Sanchez-Yague A, Salord S, Ruiz-Osuna S, Busquets J, Sanllorente-Melenchon M, Videla S, Moreno R, Tebe-Cordomi C, Hereu P, Vazquez-Sequeiros E; Spanish Working Group on Pancreatic Collection Therapy. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial. Surg Endosc. 2024 Apr;38(4):2148-2159. doi: 10.1007/s00464-024-10699-w. Epub 2024 Mar 6.
- Derived from this study: PubMed 31888751Gornals JB, Perez-Miranda M, Vazquez-Sequeiros E, Vila J, Esteban JM, Gonzalez-Huix F, Guarner-Argente C, Sanchez-Yague A, Teran A, Bas-Cutrina F, De La Serna C, De Paredes AG, Ballester R, Velasquez-Rodriguez J, Salord S, Tebe C, Hereu P, Videla S; Spanish Working Group on Pancreatic Collection Therapy. Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol. Trials. 2019 Dec 30;20(1):791. doi: 10.1186/s13063-019-3988-x.
- 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.
JOAN B GORNALS, MD, PhD principal investigator
Hospital Universitari de Bellvitge
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WOPN TRANSMURAL DRAINAGE: PLASTIC STENT and WOPN TRANSMURAL DRAINAGE: METALLIC STENT in people with Pancreas Necrosis and Pancreatic Collection, run by Hospital Universitari de Bellvitge at 8 sites in Spain.
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 4 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
RADIOLOGICAL SUCCESS (time frame: 4 weeks). 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 NCT03100578, which also lists 2 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 10 Nov 2021.