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Überleben, Mortalität und Lebensqualität nach pyloruserhaltender oder klassischer Whipple-Operation

Systematische Übersichtsarbeit mit Metaanalyse

Survival, mortality and quality of life after pylorus-preserving or classical Whipple operation

A systematic review with meta-analysis

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Zusammenfassung

Hintergrund

Zur chirurgischen Therapie des Pankreaskopfkarzinoms und des periampullären Karzinoms stehen die pyloruserhaltende und die klassische Operation nach Whipple („pylorus-preserving Whipple“ und „classical Whipple“) zur Verfügung.

Methoden

Die vorliegende Arbeit stellt eine Erweiterung einer in Annals of Surgery publizierten systematischen Übersichtsarbeit mit Metaanalyse dar. Mithilfe einer systematischen Suchstrategie wurde in den Datenbanken MEDLINE, EMBASE und THE Cochrane Library (CENTRAL) nach kontrollierten und randomisierten kontrollierten Studien (RCT) zum Vergleich der klassischen Whipple-Operation und der pyloruserhaltende Pankreatikoduodenektomie gesucht. Eine auf dem Random-effects-Modell basierende Metaanalyse wurde für die Endpunkte Überleben (Hazard Ratios, HR) und postoperative Mortalität (Odds Ratio, OR) durchgeführt. Die postoperative Lebensqualität konnte nicht quantitativ im Sinne einer Metaanalyse analysiert werden und wurde daher qualitativ zusammengefasst. Subgruppen- und Sensitivitätsanalysen wurden nach Studientyp (RCTs, prospektive Studien, PS, retrospektive Studien, RS), Studienqualität und Tumorlokalisation durchgeführt.

Ergebnisse

Die systematische Literatursuche ergab 4503 Suchresultate, von denen 4460 nicht den Einschlusskriterien entsprachen. 23 Studien mit insgesamt 3893 Patienten wurden eingeschlossen (6 RCTs, 12 PS und 25 RS).

Für Patienten mit Pankreaskopfkarzinom (RCTs: HR 0,80; 95%-KI 0,53–1,22; p=0,16; PS: HR 0,84; 95%-KI 0,7–1,0; p=0,95; RS: HR 0,84; 95%-KI 0,7–1,01; p=0,21) und periampullären Karzinom (RCTs: HR 1,02; 95%-KI 0,49–2,13; p=0,3; PS: HR 1,26; 95%-KI 0,46–3,42; p=0,65; RS: HR 0,86; 95%-KI 0,6–1,24; p=0,33) zeigte sich in den einzelnen Studientypen kein Unterschied im Überleben. Im Vergleich der beiden Operationsmethoden unterschied sich die postoperative Mortalität nicht signifikant (RCTs: OR 0,49; 95%-KI 0,17–1,4; p=0,18; PS: OR 0,63; 95%-KI 0,34–1,18; p=0,15; RS: OR 0,7; 95%-KI 0,37–1,31; p=0,27). Die postoperative Lebensqualität wurde in den einzelnen Studien entweder als nicht unterschiedlich oder als besser nach pyloruserhaltender Operation beschrieben.

Schlussfolgerung

Diese systematische Übersichtsarbeit zeigt bei insgesamt eingeschränkter Qualität der eingeschlossenen Studien keine Unterschiede für Überleben, Mortalität und Lebensqualität im Vergleich der pyloruserhaltenden und der klassischen Whipple-Operation. Die Bestätigung dieser Ergebnisse durch eine große, pragmatische randomisiert kontrollierte Studie erscheint sinnvoll.

Abstract

Background

Two surgical procedures are mainly performed for the treatment of pancreatic head cancer and periampullary carcinoma: the classical Whipple operation and the pylorus-preserving Whipple operation.

Methods

This manuscript represents an extension of a systematic review and meta-analysis previously published in the Annals of Surgery. A systematic literature search was performed in MEDLINE, EMBASE and the Cochrane Library (central) to identify randomized controlled trials (RCTs) and observational studies. A meta-analysis based on a random-effects model was performed for the hazard ratios (HR) of survival and the odds ratios (OR) of postoperative mortality. The results of the different studies on quality of life (QoL) could not be summarized quantitatively in a meta-analysis and were therefore summarized qualitatively. Subgroup analyses were performed by study type, RCTs, prospective cohort studies (PSs), retrospective cohort studies (RSs), study quality and tumor localization (pancreatic head cancer versus periampullary carcinoma).

Results

The systematic literature search retrieved 4,503 studies of which 4,460 did not fulfill the inclusion criteria. The remaining 43 studies (6 RCTs, 12 PSs and 25 RSs) representing 3,893 patients were finally included in the review.

There was neither a significant survival difference for patients with pancreatic head cancer in the pooled estimate of the RCTs (HR 0.80; 95% CI 0.53–1.22; p=0.16) nor in the pooled estimate of the PSs (HR 0.84; 95% CI 0.7–1.0; p=0.95) or the RSs (HR 0.84; 95% CI 0.7–1.01; p=0.21). Survival of patients with periampullary carcinoma was not significantly different in the RCTs (HR 1.02; 95% CI 0.49–2.13; p=0.3), the PSs (HR 1.26; 95% CI 0.46–3.42; p=0.65) or the RSs (HR 0.86; 95% CI 0.6–1.24; p=0.33).

Postoperative mortality was not significantly different after both types of operations (RCTs: HR 0.49; 95% CI 0.17–1.4; p=0.18; PSs: HR 0.63; 95% CI 0.34–1.18; p=0.15; RSs: HR 0.7; 95% CI 0.37–1.31; p=0.27). QoL was reported as either the same in both groups or in favor of the pylorus-preserving Whipple operation.

Conclusions

Mortality, survival and QoL were not significantly different between the classical Whipple and the pylorus-preserving Whipple operations. Given the poor quality of the underlying trials a pragmatic RCT is recommended to prove the findings of this systematic review.

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Danksagungen

Die Autoren möchten Dr. Roberta Scherer, Professor Kay Dickersin und allen Mitgliedern des US Cochrane Zentrums ebenso wie Jayne Tierney und Matthew Sydes von der MRC-Clinical Trials Unit in London für ihre Unterstützung danken.

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  1. Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC), Heidelberg, Deutschland

    C. Fitzmaurice, C.M. Seiler &  M.K. Diener

  2. Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Deutschland

    C.M. Seiler, M.W. Büchler &  M.K. Diener

  3. Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

    C. Fitzmaurice

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  1. C. Fitzmaurice
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  2. C.M. Seiler
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  3. M.W. Büchler
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  4. M.K. Diener
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Correspondence to M.K. Diener.

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Fitzmaurice, C., Seiler, C., Büchler, M. et al. Überleben, Mortalität und Lebensqualität nach pyloruserhaltender oder klassischer Whipple-Operation. Chirurg 81, 454–471 (2010). https://doi.org/10.1007/s00104-009-1829-2

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