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

NCT03100578 | Completed DMC

• 1 other identifier: PROMETHEUS
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 8

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.

Conditions

Pancreas Necrosis; Pancreatic Collection

Keywords

PANCREAS; ENDOSCOPIC INTERVENTION; PLASTIC STENT; SELF EXPANDING METALLIC STENT; ENDOSCOPIC TRANSMURAL DRAINAGE; WALLED OFF PANCREATIC NECROSIS

Outcome Measures

Primary Outcomes (1)

• RADIOLOGICAL SUCCESS

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

  4 weeks

Secondary Outcomes (5)

• CLINICAL SUCCESS

  4 month

• TECHNICAL ASPECTS

  1st day

• INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]

  1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month

• RECURRENCES

  4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month

• COSTS ANALYSIS

  12 month

Other Outcomes (3)

• TECHNICAL ASPECTS

  1st day

• TECHNICAL ASPECTS

  1st day

• TECHNICAL ASPECTS

  1st day

Study Arms (2)

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.

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.

Device: WOPN TRANSMURAL DRAINAGE: METALLIC STENT

Interventions

WOPN TRANSMURAL DRAINAGE: PLASTIC STENT DEVICE

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

PLASTIC STENT

WOPN TRANSMURAL DRAINAGE: METALLIC STENT DEVICE

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

SELF EXPANDABLE METALLIC STENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Carlos III Health Institute: collaborator
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (8)

Hospital Arnau de Vilanova

Lleida, Barcelona, 25198, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Hospital San Juan de Dios

Pamplona, Navarre, 31006, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Valldolid, 47012, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (2)

• 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.

  PMID: 38448625 DERIVED

• 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.

  PMID: 31888751 DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• JOAN B GORNALS, MD, PhD

  Hospital Universitari de Bellvitge - IDIBELL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: June 27, 2017
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)