Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients - 25/09/11
The WallFlex Colonic Registry Group
Reprint requests: Søren Meisner, MD, Bispebjerg Hospital, Bispebjerg Bakke 23, entr. 7B, DK-2400 Copenhagen NV, DenmarkRésumé |
Background |
The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery.
Objective |
To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS).
Design |
Prospective clinical cohort study.
Setting |
Two global registries with 39 academic and community centers.
Patients |
This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified).
Intervention |
Colorectal through-the-scope SEMS placement.
Main Outcome Measurements |
The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications.
Results |
The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding.
Limitations |
No control group. No primary endpoint analysis data for 25% of patients.
Conclusion |
This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low.
Le texte complet de cet article est disponible en PDF.Abbreviations : ASA, BTS, IRB, PAL, SEMS
Plan
| DISCLOSURE: S. Meisner is a consultant for Boston Scientific and Coloplast Denmark, and F. González-Huix is a consultant for Shering Plough. The WallFlex-eR colonic international and Spanish registries were sponsored by Boston Scientific Corporation. No other financial relationships relevant to this publication were disclosed |
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| The WallFlex Colonic Registry Group: Søren Meisner, MD, Bispebjerg Hospital, Copenhagen, Denmark, Ferran González-Huix, MD, Hospital Doctor Josep Trueta, Girona, Spain, Jo G. Vandervoort, MD, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium, Paul Goldberg, MD, Groote Schuur Hospital, Cape Town, South Africa, Juan A. Casellas, MD, Hospital General Universitario de Alicante, Alicante, Spain, Oscar Roncero, MD, Hospital La Mancha Centro, Alcazar de San Juan, Spain, Karl E. Grund, MD, University Hospital Tuebingen, Department of General, Visceral, and Transplantation Surgery, Tuebingen, Germany, Alberto Alvarez, MD, Hospital Universitario de Salamanca, Salamanca, Spain, Jesus García-Cano, MD, PhD, Hospital Virgen de La Luz, Cuenca, Spain, Enrique Vázquez-Astray, Complejo Hospitalario Pontevedra, Pontevedra, Spain, Javier Jiménez-Pérez, MD, Hospital de Navarra, Pamplona, Spain, Javier Barcenilla, MD, Hospital Rio Carrion, Palencia, Spain, Alessandro Repici, MD, Istituto Clinico Humanitas, Rozzano (Mi), Italy, Dimitrios Xinopoulos, MD, Saint Savas Hospital, Athens, Greece, Leopoldo Lopez-Roses, MD, Complejo Hospitalario Xeral-Calde, Lugo, Spain, Ovidio Belda, MD, Hospital Virgen del Rocio, Sevilla, Spain, Marc Giovannini, MD, Institut Paoli–Calmettes, Marseille, France, Jorge Espinós, MD, Fundacio Mutua de Terrassa, Terrassa, Spain, Ivan Garcia-Tercero, MD, Hospital Clinico San Cecilio, Granada, Spain, Guillermo Alcain, MD, Hospital Virgen de La Victoria, Malaga, Spain, Vicente Sanchiz, MD, Hospital Clinico de Valencia, Valencia, Spain, Luis Yuguero, MD, Hospital General Yague, Burgos, Spain, Antonio M. Pueyo, MD, Hospital Virgen del Camino, Pamplona, Spain, Paul Kortan, MD, St. Michael, Toronto, Canada, Truls Hauge, MD, Ullevål University Hospital, Oslo, Norway, António J. Marques, MD, De Santa Maria Epe, Lisboa, Portugal, Santiago Rodriguez, MD, Hospital Virgen de La Concha, Zamora, Spain, Francesc Vida, MD, Hospital de Manresa-Althaia, Manresa, Spain, Leopoldo Martin-Herrera, MD, Hospital Puerta del Mar, Cadiz, Spain, Antonio Naranjo, MD, Hospital Universitario Reina Sofia, Cordoba, Spain, Michael Hünerbein, MD, Helios Robert-Rössle-Klinik, Berlin, Germany, Maria Gloria Fernandez, Hospital Clinic I Provincial de Barcelona, Barcelona, Spain, Antonio Lopez-Serrano, MD, Hospital Universitario Dr Peset, Valencia, Spain, Angelo Ferrari, MD, Instituto Paulista de Gastroenterología, São Paulo, Brazil, Blanca Ferreiro, MD, Hospital Carlos Haya, Malaga, Spain, Victor Orive, MD, Hospital de Basurto, Bilbao, Spain, Vicente Sanchiz, MD, Complejo Hospitalario de Orense, Orense, Spain, Prem Premchand, MD, Oldchurch Hospital (The New Queens Hospital), Romford, United Kingdom, Juan A. Gonzalez, Hospital Ramon Y Cajal, Majadahonda, Spain, Joyce Peetermans, PhD, Lina Ginnetti, MA, Robert Walsh, MD, Matthew Rousseau, Boston Scientific, Natick, Massachusetts, USA |
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| Presented at United European Gastroenterology Week, October 18-22, 2008, Vienna, Austria (Endoscopy 2008;40[suppl 1]:A6-A7). |
Vol 74 - N° 4
P. 876-884 - octobre 2011 Retour au numéro
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