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Completed

NCT Number: NCT03100578

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

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.

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Key information

Conditions

Pancreas Necrosis Digestive System Diseases Pancreatic Collection Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Arnau de Vilanova, Lleida, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

  1. RADIOLOGICAL SUCCESS

    Time frame: 4 weeks

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

Secondary outcomes

  1. CLINICAL SUCCESS

    Time frame: 4 month

    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.

  2. TECHNICAL ASPECTS

    Time frame: 1st day

    Evaluate the technical success, duration of the procedure and level of difficulty.

  3. 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

    Assess safety: complications (immediate, early and late)

  4. RECURRENCES

    Time frame: 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month

    Evaluate recurrences

  5. COSTS ANALYSIS

    Time frame: 12 month

    Evaluate the costs between the two types of strategy

Other outcomes

  1. TECHNICAL ASPECTS

    Time frame: 1st day

    Technical success: Correct release of the prosthesis (plastic or metallic) and drainage of the WOPN.

  2. TECHNICAL ASPECTS

    Time frame: 1st day

    Duration of the procedure: Minutes

  3. TECHNICAL ASPECTS

    Time frame: 1st day

    Level of difficulty: Easy, Medium, Hard, Very hard

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Carlos III Health Institute
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.

Acronym: PROMETHEUS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2017
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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