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EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis. (PROMETHEUS)

Primary Purpose

Pancreas Necrosis, Pancreatic Collection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
WOPN TRANSMURAL DRAINAGE: PLASTIC STENT
WOPN TRANSMURAL DRAINAGE: METALLIC STENT
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Necrosis focused on measuring PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Hospital Arnau de Vilanova
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Costa del Sol
  • Hospital San Juan de Dios
  • Hospital Universitario Río Hortega
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Ramón y Cajal
  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PLASTIC STENT

SELF EXPANDABLE METALLIC STENT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

RADIOLOGICAL SUCCESS
Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.

Secondary Outcome Measures

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.
TECHNICAL ASPECTS
Evaluate the technical success, duration of the procedure and level of difficulty.
INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]
Assess safety: complications (immediate, early and late)
RECURRENCES
Evaluate recurrences
COSTS ANALYSIS
Evaluate the costs between the two types of strategy

Full Information

First Posted
March 29, 2017
Last Updated
November 9, 2021
Sponsor
Hospital Universitari de Bellvitge
Collaborators
Carlos III Health Institute, Spanish Clinical Research Network - SCReN
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1. Study Identification

Unique Protocol Identification Number
NCT03100578
Brief Title
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.
Acronym
PROMETHEUS
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
Carlos III Health Institute, Spanish Clinical Research Network - SCReN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Necrosis, Pancreatic Collection
Keywords
PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLASTIC STENT
Arm Type
Experimental
Arm Description
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.
Arm Title
SELF EXPANDABLE METALLIC STENT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WOPN TRANSMURAL DRAINAGE: PLASTIC STENT
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
WOPN TRANSMURAL DRAINAGE: METALLIC STENT
Intervention Description
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
Primary Outcome Measure Information:
Title
RADIOLOGICAL SUCCESS
Description
Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
CLINICAL SUCCESS
Description
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.
Time Frame
4 month
Title
TECHNICAL ASPECTS
Description
Evaluate the technical success, duration of the procedure and level of difficulty.
Time Frame
1st day
Title
INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]
Description
Assess safety: complications (immediate, early and late)
Time Frame
1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
Title
RECURRENCES
Description
Evaluate recurrences
Time Frame
4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
Title
COSTS ANALYSIS
Description
Evaluate the costs between the two types of strategy
Time Frame
12 month
Other Pre-specified Outcome Measures:
Title
TECHNICAL ASPECTS
Description
Technical success: Correct release of the prosthesis (plastic or metallic) and drainage of the WOPN.
Time Frame
1st day
Title
TECHNICAL ASPECTS
Description
Duration of the procedure: Minutes
Time Frame
1st day
Title
TECHNICAL ASPECTS
Description
Level of difficulty: Easy, Medium, Hard, Very hard
Time Frame
1st day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOAN B GORNALS, MD, PhD
Organizational Affiliation
Hospital Universitari de Bellvitge - IDIBELL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Arnau de Vilanova
City
Lleida
State/Province
Barcelona
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hospital San Juan de Dios
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31006
Country
Spain
Facility Name
Hospital Universitario Río Hortega
City
Valladolid
State/Province
Valldolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31888751
Citation
Gornals 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.
Results Reference
derived

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EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.

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