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Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial

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Abstract

Background

Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS.

Methods

This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. ClinicalTrials.gov, NCT03100578.

Results

A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88–2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92–1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, − 10 [95% CI − 17.5, − 1]; p = 0.077) and global hospitalization (median difference − 4 [95% CI − 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08–0.83], p = 0.015).

Conclusions

The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed.

Trial registration number

ClinicalTrials.gov, NCT03100578.

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Acknowledgements

To Maria Puigcerver-Mas for her selfless artwork (visual abstract). To the collaborators of the Spanish Working Group on Pancreatic Collection who have contributed to the study: Sergi Bazaga and Claudia F Consiglieri (Endoscopy Unit, Hospital Universitari de Bellvitge, Barcelona), Manuel Vazquez-Romero (Endoscopy Unit, Hospital Clinico San Carlos, Madrid), and Raquel Ballester (Hospital Arnau de Vilanova, Lleida) who assisted in the enrolment of patients. Monica Domi from Clinical Research and Clinical Trial Unit (UICEC IDIBELL), SCReN platform, applying the different amendments to each version of the trial protocol. David Leiva from Radiology department, of Hospital Universitari de Bellvitge, for his imaging report assistance. To the Spanish Platform of Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), financed by the ISCIII-General Sub directorate for the Evaluation and Promotion of Research, through project PT13 / 0002/00585 integrated in the State Plan of R + D + I 2013–2016 and co-financed by and the European Regional Development Fund (FEDER). To the Spanish Society of Digestive Endoscopy (SEED, beca investigación 2015); and to the Catalan Society of Gastroenterology (SCD, beca d’intensificació 2016). To the CERCA Programme/Generalitat de Catalunya for institutional support.

Funding

The PROMETHEUS study was supported by a grant (PI15/00585, 2015) from the Instituto-de-Salud-Carlos-III (ISCIII), Ministry of Economy and Competitiveness (Spain), and cofinanced by the European Development Regional Fund ‘‘A way to achieve Europe’’; a grant from the Spanish Society of Digestive Endoscopy (SEED) in 2015; and from the Catalan Society of Gastroenterology (SCD) in 2016. The funding bodies had no role in the trial design or interpretation of the data.

Author information

Author notes

  1. Joan B. Gornals and Julio G. Velasquez-Rodriguez have contributed equally to this work.

Authors and Affiliations

  1. Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Feixa Llarga s/n, 08907, L’Hospitalet, Barcelona, Catalonia, Spain

    Joan B. Gornals, Julio G. Velasquez-Rodriguez, Francesc Bas-Cutrina & Albert Garcia-Sumalla

  2. Universitat de Barcelona (UB), Barcelona, Catalonia, Spain

    Joan B. Gornals, Julio G. Velasquez-Rodriguez, Francesc Bas-Cutrina, Albert Garcia-Sumalla, Sebas Videla, Cristian Tebe-Cordomi & Pilar Hereu

  3. Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain

    Joan B. Gornals, Julio G. Velasquez-Rodriguez, Francesc Bas-Cutrina, Albert Garcia-Sumalla, Silvia Salord, Sandra Ruiz-Osuna, Juli Busquets, Mireia Sanllorente-Melenchon, Sebas Videla, Cristian Tebe-Cordomi & Pilar Hereu

  4. Endoscopy Unit, Gastroenterology and Hepatology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain

    Ana Garcia Garcia De Paredes, Jose Ramon Foruny & Enrique Vazquez-Sequeiros

  5. Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain

    Ana Garcia Garcia De Paredes, Jose Ramon Foruny & Enrique Vazquez-Sequeiros

  6. Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico San Carlos, Madrid, Spain

    Jose-Miguel Esteban & Joaquin Fisac-Vazquez

  7. Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Alvaro Teran & Maria Moris

  8. Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Arnau de Vilanova, Lleida, Catalonia, Spain

    Ferran Gonzalez-Huix & Isabel Miquel-Salas

  9. Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain

    Manuel Perez-Miranda & Carlos De-la-Serna Higuera

  10. Endoscopy Unit, Digestive Pathology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain

    Carlos Guarner-Argente & Marianette Murzi-Pulgar

  11. Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario de Navarra, Pamplona, Spain

    Juan J. Vila

  12. Endoscopy Unit, Department of Digestive Diseases, Hospital Costa del Sol, Marbella, Spain

    Andres Sanchez-Yague

  13. Hepato-Bilio-Pancreatic Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain

    Silvia Salord

  14. Radiology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain

    Sandra Ruiz-Osuna

  15. Hepato-bilio-Pancreatic Unit, Department of General Surgery, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain

    Juli Busquets

  16. Clinical Research and Clinical Trial Unit (UICEC), Plataforma Spanish Clinical Research Network (SCRen), Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain

    Mireia Sanllorente-Melenchon, Sebas Videla & Pilar Hereu

  17. Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain

    Sebas Videla & Pilar Hereu

  18. Economics and Finance Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain

    Ramon Moreno

  19. Biostatistics Department, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain

    Cristian Tebe-Cordomi

Authors
  1. Joan B. Gornals
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  2. Julio G. Velasquez-Rodriguez
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  3. Francesc Bas-Cutrina
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Consortia

The Spanish Working Group on Pancreatic Collection Therapy

  • Sergi Bazaga
  • , Claudia F. Consiglieri
  • , Manuel Vazquez-Romero
  • , Raquel Ballester
  • , Monica Domi
  •  & David Leiva

Contributions

EVS, MPM, JJV, and JBG conceived the project. SV, MPM, EVS, JJV, PH, CT, and JBG participated in the design of the study. The study design was discussed in research meetings with all authors. JGV, FBC, AGG, JME, AT, FGH, MPM, CGA, JJV, AGS, JRF, JFV, MM, IMS, CSH, MMP, ASY, SRO, and JB promoted the enrolment of patients, conducted the study, and acquired the data. JGV, and JBG collected, interpreted, and analyzed the data, and verified the underlying data. JGV, FBC, PH, SV, and JBG coordinated the study. JGV, CT, and JBG did the statistical analysis. RM, JGV, and JBG calculated the cost analysis. JBG drafted the manuscript under supervision of EVS. All authors read, revised, and provided a critical review of the draft manuscript. All authors approved the final manuscript. JBG had final responsibility for the decision to submit for publication.

Corresponding author

Correspondence to Joan B. Gornals.

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Disclosures

M. Perez-Miranda is consultant and speaker for Medtronic, Olympus, Taewoong, Boston Sc and M. I. Tech; E Vazquez-Sequeiros is consultant for Boston Sc; F Gonzalez-Huix is consultant for Boston Sc; JB Gornals is consultant for Boston Sc and Fujifilm; JG Velasquez is a PhD student at the Universitat de Barcelona, and this paper is part of his doctoral project. JB Gornals acts as a PhD Director. Francesc Bas-Cutrina, Ana Garcia Garcia De Paredes, Jose-Miguel Esteban, Alvaro Teran, Carlos Guarner-Argente, Juan J Vila, Albert Garcia-Sumalla, Jose Ramon Foruny, Joaquin Fisac-Vazquez, Maria Moris, Isabel Miquel-Salas, Carlos De-la-Serna Higuera, Marianette Murzi-Pulgar, Andres Sanchez-Yague, Silvia Salord, Sandra Ruiz-Osuna, Juli Busquets, Mireia Sanllorente-Melenchon, Sebas Videla, Ramon Moreno, Cristian Tebe-Cordomi, Pilar Hereu have no conflict of interest or financial ties to disclose.

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Gornals, J.B., Velasquez-Rodriguez, J.G., Bas-Cutrina, F. et al. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial. Surg Endosc 38, 2148–2159 (2024). https://doi.org/10.1007/s00464-024-10699-w

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