Vergleich von Operation und endoskopischer Stentimplantation beim linksseitigen kolorektalen Karzinom im Stadium IV – vorzeitiger Abbruch einer multizentrischen randomisierten klinischen Studie

Zusammenfassung

Hintergrund und Studienziele: Die Einführung selbstexpandierender Metallstents hat eine viel versprechende Alternative für die Palliation maligner Stenosen des linksseitigen Kolons eröffnet. Die vorliegende randomisierte Studie sollte prüfen, ob ein nicht chirurgisches Vorgehen mit intraluminaler Stentimplantation der chirurgischen Behandlung von Patienten mit linksseitigem kolorektalen Karzinom im Stadium IV und drohendem Darmverschluss überlegen ist. Patienten und Methode: Patienten mit inkurablen linksseitigem kolorektalen Karzinom, die die Studienkriterien erfüllten, wurden entweder in eine nicht chirurgische oder eine chirurgische Behandlung randomisiert. Primärer Studienendpunkt war das Überleben in gutem Allgemeinzustand außerhalb des Krankenhauses (WHO-Score 0 oder 1). Ergebnisse: Eine hohe Anzahl schwerer unerwünschter Ereignisse im nicht chirurgischen Arm führte zum vorzeitigen Abschluss der Studie. 10 Patienten waren dem chirurgischen Arm und 11 Patienten der nicht chirurgischen Palliation zugeordnet worden. Das mediane Überleben außerhalb des Krankenhauses in gutem Allgemeinzustand betrug im ersten Jahr 56 Tage (interquartiler Bereich 7,5 bis 338,5 Tage) im chirurgischen Arm und 38 Tage (interquartiler Bereich 5,25 bis 288,75 Tage) im nicht chirurgischen Arm (p = 0,68). Elf unerwünschte Ereignisse (6 Perforationen) traten im nicht chirurgischen Arm und ein unerwünschtes Ereignis trat im chirurgischen Arm auf (p < 0,001). Von den 6 Perforationen waren 2 Stent-verursacht, weil sie am proximalen Ende des Stents durch Erosion durch die normale Dickdarmwand aufgetreten waren; eine war wahrscheinlich Stent-verursacht (sie war in der Region proximalen Hälfte des Stents lokalisiert); eine war Folge einer Kolonruptur und zwei waren späte Tumorperforationen bei Patienten, die eine Chemotherapie erhielten. Schlussfolgerungen: Die unerwartet hohe Rate von Perforationen im nicht chirurgischen Arm könnte spezifisch mit dem Wallflex-Stent oder enteralen Stent bei Patienten im Zusammenhang stehen, die eine Chemotherapie erhalten. Sie verdient besondere Aufmerksamkeit.

Abstract

Background and study aims: The introduction of self-expandable metal stents has offered a promising alternative for palliation of malignant left-sided colonic obstruction. This randomized clinical trial aimed to assess whether a nonsurgical policy, with endoluminal stenting, is superior to surgical treatment in patients with stage IV left-sided colorectal cancer and imminent obstruction. Patients and methods: Patients with incurable left-sided colorectal cancer who fulfilled the study criteria were randomly assigned to nonsurgical or surgical treatment. The primary outcome measure was survival in good health out of hospital (World Health Organization performance scores 0 or 1). Results: A high number of serious adverse events in the nonsurgical arm led to premature closure of the trial. Ten patients were allocated to surgical treatment and 11 patients to nonsurgical palliation. The median survival in good health out of hospital during the first year was 56 days (interquartile range 7.5–338.5 days) in the surgical arm vs. 38 days (interquartile range 5.25–288.75 days) in the nonsurgical arm (p = 0.68). Eleven adverse events (six perforations) occurred in the nonsurgical arm vs. one adverse event in the surgical arm (p > 0.001). Of the six perforations, two were stent-related because they occurred at the proximal edge of the stent by erosion through a normal colon wall; one was probably stent-related (it was located in the region of the proximal half of the stent); one was a colon blowout; and two were late tumor perforations in patients on chemotherapy. Conclusions: The unexpected high rate of perforation in the nonsurgical arm might be specifically WallFlex-related or enteral stent-related in patients on chemotherapy and warrants attention.

Schlüsselwörter

Kolonkarzinom - Darmobstruktion - Stentimplantation - randomisierte Studie

Key words

colorectal cancer - bowel obstruction - surgery - stenting - randomized trial

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