Konsekutiver Vergleich von 3 verschiedenen Typen selbstexpandierender Metallstents zur Palliation der malignen Dysphagie: Ergebnisse aus dem prospektiven Ludwigshafener Ösophagus-Stentregister

Zusammenfassung

Hintergrund: Das endoskopische Stenting mit selbstexpandierenden Metallstents (SEMS) hat sich als palliative endoskopische Therapieoption bei maligner Dysphagie bewährt. Verschiedene Typen von SEMS wurden bislang in kleineren randomisierten Studien untersucht. Methodik: Von 1/1995 - 1/2004 wurden insgesamt 150 konsekutive Patienten (Pt.) (35 Frauen, 115 Männer), medianes Alter 66 (43 - 94) Jahre in die Auswertung eingeschlossen. Drei Typen von SEMS kamen zum Einsatz: (Gruppe A: Gianturco-Z®-Stent, n = 59 Pt.; Gruppe B: Ultraflex®-Stent, n = 49 Pt.; Gruppe C: Flamingo-Wallstent®, n = 42 Pt.). Die Dysphagie wurde in Schweregrad 0 (keine Dysphagie) bis Schweregrad 4 (totale Obstruktion) eingeteilt. Ergebnisse: Eine erfolgreiche Stenteinlage wurde bei 55/59 (93 %) Pt. der Gruppe A, 47/49 (96 %) Pt. der Gruppe B und 40/42 (95 %) Pt. der Gruppe C evaluiert (p = 0,78). Postinterventionell konnte eine Reduktion des Dysphagiescore in Gruppe A (von 2,77 auf 0,99), Gruppe B (2,58 auf 0,72) und Gruppe C (2,62 auf 0,81) verzeichnet werden (p = 0,37). Patienten der Gruppe B zeigten eine tendenziell längere Dysphagiefreiheit (Gruppe A: 78 Tage, Gruppe B: 90 Tage, Gruppe C: 70 Tage) (p = 0,45). Das mediane Überleben lag bei 96 Tagen (Gruppe A), 118 Tagen (Gruppe B) und 108 Tagen (Gruppe C) (p = 0,18). Höhergradige Komplikationen boten 20/59 (34 %) Pt. der Gruppe A, 8/49 (16 %) und 7/42 (17 %) Pt. der Gruppen B und C (p = 0,04). Schlussfolgerungen: In der Behandlung der malignen Dysphagie zeigten alle 3 untersuchten SEMS-Typen eine vergleichbare Effektivität. Allerdings war der Gianturco-Z®-Stent im Vergleich zum Ultraflex®-Stent und zum Flamingo-Wallstent® mit einer signifikant höheren Komplikationsrate verbunden.

Abstract

Background: Endoscopic stenting with self-expanding metal stents (SEMS) has proved to be an efficient palliative endoscopic therapy option in treating malignant dysphagia. Different types of SEMS have been examined previously in small randomized clinical trials. Methods: A total of 150 consecutive patients (from 1/1995 - 1/2004; 35 females, 115males) with a median age of 66 years (range 43 - 94 years) were evaluated. Three different types of SEMS were examined: Group A: Gianturco Z® Stent n = 59 pts.; Gruppe B: Ultraflex® Stent n = 49 pts.; Gruppe C: Flamingo Wallstent® n = 42 pts.). Dysphagia was categorized into grade 0 (no dysphagia) to grade 4 (total obstruction). Results: Stent insertion was successfully evaluated in 55/59 (93 %) of the patients in group A, in 47/49 (96 %) of the patients in group B and in 40/42 (95 %) of the patients in group C (p = 0.78). After stent insertion, a reduction in the dysphagia score from 2.77 to 0.99 was observed in group A, from 2.58 to 0.72 in group B and from 2.62 to 0.81 in group C (p = 0.37). The median time to dysphagia recurrence was 78 days in group A, 90 days in group B and 70 days in group C (p = 0.45). The median overall survival time was 96 days in group A, 118 days in group B and 108 days in group C (p = 0.18). The incidence of high grade complications was 34 % in group A, 16 % in group B and 17 % in group C (p = 0.04). Conclusions: The 3 types of SEMS examined in this study showed similar efficacies in treating malignant dysphagia. However, the major complication rate of the Gianturco Z® stent was significantly higher when compared to the complication rate of the Ultraflex® stent and the Flamingo Wallstent®.

Schlüsselwörter

Selbstexpandierende Metallstents (SEMS) - maligne Dysphagie - Palliation - endoskopische Stenttherapie

Key words

Self-expanding metal stents (SEMS) - malignant dysphagia - palliation - endoscopic stenting

Literatur

• 1 Allum W H, Griffin S M, Watson A. et al . Guidelines for the management of esophageal and gastric cancer.  Gut. 2002;  50 (suppl V) v1-v23
• 2 Eickhoff A, Jakobs R, Riemann J F. Palliative treatment options for esophageal and gastric cancer.  Internist (Berl). 2004;  45 (7) 756-768
• 3 Nash C L, Gerdes H. Methods of palliation of esophageal and gastric cancer.  Surg Oncol Clin N Am. 2002;  11 459-483
• 4 Siersema P D, Dees J, van Blankenstein M. Palliation of malignant dysphagia from esophageal cancer.  Scand J Gastroenterol. 1998;  33 75-84
• 5 Adler D G, Baron T H. Endoscopic palliation of malignant dysphagia.  Mayo Clin Proc. 2001;  76 731-738
• 6 Lambert R. Treatment of Esophagogastric Tumors.  Endoscopy. 2003;  35 118-126
• 7 Kozarek R A. Endoscopic palliation of esophageal malignancy.  Endoscopy. 2003;  35 S9-S13
• 8 Leiper K, Morris A I. Treatment of esophago-gastric tumors.  Endoscopy. 2002;  34 139-145
• 9 Conio M, Repici A, Battaglia G. et al . A prospective, randomized study comparing two self-expanding stents in the palliation of patients with dysphagia due to inoperable esophageal cancer.  Gastrointest Endosc. 2004;  W 1552 A-930
• 10 Homs M Y, Steyerberg E W, Kuipers E J. et al . Causes and treatment of recurrent dysphagia after self-expanding metal stent placement for palliation of esophageal carcinoma.  Endoscopy. 2004;  36 880-886
• 11 Yajima K, Kanda T, Nakagawa S. et al . Self-expandable metallic stents for palliation of malignant esophageal obstruction: special reference to quality of life and survival of patients.  Dis Esophagus. 2004;  17 71-75
• 12 Frimberger E. Expanding spiral- a new type of prosthesis for the palliative treatment of malignant esophageal stenosis.  Endoscopy. 1983;  15 213-214
• 13 Kozarek R A, Ball T J, Patterson D J. Metallic self-expanding stent application in the upper gastrointestinal tract: caveats and concerns.  Gastrointest Endosc. 1992;  38 1-6
• 14 Knyrim K, Wagner H J, Bethge N. et al . A controlled trial of an expansile metal stent for palliation of esophageal obstruction due to inoperable cancer.  New Engl J Med. 1993;  329 1302-1307
• 15 Siersema P D, Hop C J, Dees J. et al . Coated self expanding metal stents versus latex prostheses for esophagogastric cancer with special reference to prior radiation and chemotherapy: a controlled, prospective study.  Gastrointest Endosc. 1998;  46 113-119
• 16 Birch J F, White S A, Berry D P. et al . A cost-benefit comparison of self expanding metal stents and Atkinson tubes for the palliation of obstructing esophageal tumors.  Dis Esophagus. 1998;  11 172-176
• 17 De Palma G D, Di Matteo E, Romano G. et al . Plastic prosthesis versus expandable metal stents for palliation of inoperable esophageal thoracic carcinoma: a controlled prospective study.  Gastrointest Endosc. 1996;  43 478-482
• 18 Kozarek R A, Ball T J, Brandabur J J. et al . Expandable versus conventional esophageal prostheses: easier insertion may not preclude subsequent stent-related problems.  Gastrointest Endosc. 1996;  43 204-208
• 19 Roseveare C D, Patel P, Simmonds N. et al . Metal stents improve dysphagia, nutrition and survival in malignant oesophageal stenosis: a randomized controlled trial comparing modified Gianturco Z-stents with plastic Atkinson tubes.  Eur J Gastroenterol Hepatol. 1998;  10 653-657
• 20 O’Donnell C A, Fullarton G M, Watt E. et al . Randomized clinical trial comparing self-expanding metallic stents with plastic endoprostheses in the palliation of oesophageal cancer.  Br J Surg. 2002;  89 985-992
• 21 Siersema P D, Hop W C, van Blankenstein M. et al . A comparison of 3 types of covered metal stents for the palliation of patients with dysphagia caused by esophagogastric carcinoma: a prospective, randomized study.  Gastrointest Endosc. 2001;  54 269-272
• 22 Vakil N, Bethge N. Metal stents for malignant esophageal obstruction.  Am J Gastroenterol. 1996;  91 2471-2476
• 23 Ell C, Hochberger J, May A. et al . Coated and uncoated self-expanding stents for malignant stenosis in the upper GI tract: preliminary clinical experiences with wallstents.  Am J Gastroenterol. 1994;  89 1496-1500
• 24 Segalin A, Bonavina L, Carazzone A. et al . Improving results of esophageal stenting: a study on 160 consecutive unselected patients.  Endoscopy. 1997;  29 701-719
• 25 Vakil N, Morris A I, Marcon N. et al . A prospective, randomized, controlled trial of covered expandable metal stents in the palliation of malignant esophageal obstruction at the gastroesophageal junction.  Am J Gastroenterol. 2001;  96 1791-1796
• 26 Christie N A, Buenaventura P O, Fernando H C. et al . Results of expandable metal stents for malignant esophageal obstruction in 100 patients: short-term and long-term follow-up.  Ann Thorac Surg. 2001;  71 1797-1801
• 27 De Palma G D, Galloro G, Sivero L. et al . Self-expanding metal stents for palliation of inoperable carcinoma of the esophagus and gastroesophageal junction.  Am J Gastroenterol. 1995;  90 2140-2142
• 28 Sabharwal T, Hamady M S, Chui S. et al . A randomised prospective comparison of the Flamingo Wallstent and Ultraflex stent for palliation of dysphagia associated with lower third oesophageal carcinoma.  Gut. 2003;  52 922-926
• 29 Wenger U, Luo J, Lundell L. et al . A nationwide study of the use of self-expanding stents in patients with esophageal cancer in sweden.  Endoscopy. 2005;  37 329-334
• 30 Bethge N, Sommer A, Gross U. et al . Human tissue responses to metal stents implanted in vivo for the palliation of malignant stenoses.  Gastrointest Endosc. 1996;  43 596-602
• 31 Mühr-Wilkenshoff F, Stahl M, Faiss S. et al . Aktuelle Diagnostik und Therapie des Ösophaguskarzinoms.  Z Gastroenterol. 2004;  42 615-621
• 32 Bartelsman J EW, Bruno M J, Jensema A L. et al . Palliation of patients with esophagogastric neoplasms by insertion of a covered expandable modified Gianturco-Z endoprosthesis: experience in 153 patients.  Gastrointest Endosc. 2000;  51 134-138
• 33 Mayoral W, Fleischer D, Calcedo J. et al . Nonmalignant obstruction is a common problem with metal stents in the treatment of esophageal cancer.  Gastrointest Endosc. 2000;  51 556-559
• 34 Sur R K, Levin C V, Donde B. et al . Prospective randomized trial of HDR brachytherapy as a sole modality in palliation of advanced esophageal carcinoma - an International Atomic Energy Agency study.  Int J Radiat Oncol Biol Phys. 2002;  53 127-133
• 35 Homs M Y, Steyerberg E W, Eijkenboom W M. et al . Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial.  Lancet. 2004;  364 1497-1504