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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Collection; Pancreas Necrosis
• Intervention / Treatment: Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT; Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos
  • Barcelona
    • Lleida, Barcelona, Spain, 25198
      • Hospital Arnau de Vilanova
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol
  • Navarra
    • Pamplona, Navarra, Spain, 31006
      • Hospital San Juan de Dios
  • Valldolid
    • Valladolid, Valldolid, Spain, 47012
      • Hospital Universitario Río Hortega

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLASTIC STENT; 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.	Device: WOPN TRANSMURAL DRAINAGE: PLASTIC STENT; 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
Active Comparator: SELF EXPANDABLE METALLIC 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.	Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 month
TECHNICAL ASPECTS	Evaluate the technical success, duration of the procedure and level of difficulty.	1st day
INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]	Assess safety: complications (immediate, early and late)	1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
RECURRENCES	Evaluate recurrences	4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
COSTS ANALYSIS	Evaluate the costs between the two types of strategy	12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TECHNICAL ASPECTS	Technical success: Correct release of the prosthesis (plastic or metallic) and drainage of the WOPN.	1st day
TECHNICAL ASPECTS	Duration of the procedure: Minutes	1st day
TECHNICAL ASPECTS	Level of difficulty: Easy, Medium, Hard, Very hard	1st day

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Carlos III Health Institute; Spanish Clinical Research Network - SCReN
• Investigators: Principal Investigator: JOAN B GORNALS, MD, PhD, Hospital Universitari de Bellvitge - IDIBELL

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: PANCREAS; ENDOSCOPIC INTERVENTION; PLASTIC STENT; SELF EXPANDING METALLIC STENT; ENDOSCOPIC TRANSMURAL DRAINAGE; WALLED OFF PANCREATIC NECROSIS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Pancreatitis; Necrosis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: PROMETHEUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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