Endoscopy 2020; 52(S 01): S10
DOI: 10.1055/s-0040-1704039
ESGE Days 2020 oral presentations
Thursday, April 23, 2020 16:30 – 18:00 President’s opening session 3 Auditorium
© Georg Thieme Verlag KG Stuttgart · New York

MULTICENTER PROSPECTIVE RANDOMIZED STUDY TO COMPARE ENDOSCOPIC TREATMENT OF STRICTURES IN CROHN´S DISEASE (CD): SELF-EXPANDING METAL STENTS (SEMS) VS ENDOSCOPIC BALLOON DILATION (EBD). PROTDILAT STUDY

X Andújar
1   Hospital Universitari Mútua Terrassa, Endoscopy, Terrassa, Spain
2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
,
C Loras
1   Hospital Universitari Mútua Terrassa, Endoscopy, Terrassa, Spain
2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
,
JB Gornals
3   Hospital Universitari de Bellvitge, Hospitalet del Llobregat, Spain
,
J Guardiola
3   Hospital Universitari de Bellvitge, Hospitalet del Llobregat, Spain
,
V Sanchiz
4   Hospital Clínico de Valencia, Valencia, Spain
,
M Bosca
4   Hospital Clínico de Valencia, Valencia, Spain
,
E Brullet
2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
5   Consorci Sanitari Parc Taulí, Sabadell, Spain
,
B Sicilia
6   Hospital Universitario de Burgos, Burgos, Spain
,
A Naranjo
7   Hospital Reina Sofía de Córdova, Córdova, Spain
,
C Dueñas
8   Hospital San Pedro de Alcántara, Cáceres, Spain
,
JR Foruny
9   Hospital Universitario Ramón y Cajal, Madrid, Spain
,
D Busquets
10   Hospital Josep Trueta, Girona, , Spain
,
D Monfort
11   Consorci Sanitari de Terrassa, Terrassa, Spain
,
MD Martín-Arranz
12   Hospital Universitario La Paz, Madrid, Spain
,
J Barrio
13   Hospital Universitario Rio Hortega, Valladolid, Spain
,
JR Pineda
14   Complexo Hospitalario Universitario de Vigo, Vigo, Spain
,
F González-Huix
15   Clínica Girona, Girona, Spain
,
F Pérez-Roldán
16   Hospital General La Mancha-Centro, Ciudad Real, Spain
,
V Pons
17   Hospital Universitari i Politecnic La Fe, Valencia, Spain
,
B González
2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
18   Hospital Clínic Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain
,
E Sainz
19   Hospital Universitari Arnau de Vilanova, Lleida, Spain
,
J Reyes-Moreno
20   Hospital Comarcal de Inca, Inca, Spain
,
F Fernández-Bañares
1   Hospital Universitari Mútua Terrassa, Endoscopy, Terrassa, Spain
2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
,
M Esteve
1   Hospital Universitari Mútua Terrassa, Endoscopy, Terrassa, Spain
2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
› Author Affiliations
Further Information

Publication History

Publication Date:
23 April 2020 (online)

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Aims: Introduction EBD is the established endoscopic treatment for short strictures in CD. SEMS have been used for endoscopic treatment in patients that failed to dilation.

Aims 1). Efficacy and safety of endoscopic treatment (SEMSvs.EBD) in CD patients with stenosis; 2). Comparative cost study.

Methods Randomized, prospective, multicenter clinical trial of CD patients and obstructive symptoms with stenosis < 10cm and refractory to medical treatment. We exclude patients with stenosis previously treated with SEMS and/or EBD in the previous year and with stenosis no accessible to colonoscopy. The efficacy of the endoscopic treatment was defined by the percentage of patients free of a new therapeutic intervention (EBD,SEMS or surgery) due to symptomatic recurrence at one year of follow-up. A direct cost study was done.

Results 99 patients were randomized (19 excluded because they did not fulfil the inclusion criteria). Eighty patients, 39 women, with a median age of 45 (IQR:38-54.7) were finally included. The primary treatment was 39SEMS and 41EBD for ITT analysis. Success rate of EBD and SEMS was 80.5% and 51.3%, respectively (AdjustedOR,3.6;95%CI,1.3-10.2;p=0.013). In a subanalysis of patients with strictures >3cm differences between the 2 endoscopic procedures disappeared (EDB:66.7%vs.SEMS:63.6%). The length of the stricture (OR,1.01;95%CI,1.01-1.15;p=0.028) and the initial obstructive symptoms score of the patient (OR,2.91;95%CI,1.23-6.89;p=0.015) were the only factors related with the therapeutic success of EBD. A 6.3% adverse events were reported. The average cost for EBD patient was 893.27 euros (average 1.5dilations) and for SEMS patients was 1,942.16 euros.

Conclusions EDB is more effective than SEMS for CD strictures, with a good safety profile of both treatments. EBD is more cost-effective than SEMS. The length of the stricture and the initial obstructive symptoms of the patient are the only factors related to EBD success. The clinical scenario in which SEMS could be useful is strictures >3 cm. ClinicalTrials.gov NCT 02395354.