Morbidity and mortality after D1 and D2 gastrectomy for cancer: Interim analysis of the Italian Gastric Cancer Study Group (IGCSG) randomised surgical trial☆
Introduction
Large retrospective Japanese series have shown impressive survival results after D2 gastrectomy (gastric resection together with the removal of level-2 lymph nodes as standardized by the Japanese Society for Research in Gastric Cancer—JSRGC) for potentially curable gastric cancer.1., 2.
Although some non-Japanese series have also reported favourably,3., 4. these extended lymphadenectomies are still mostly avoided in western countries due to the related increase of post-operative morbidity and mortality.
During the last decade, two European prospective randomised trials have reported that D2 gastric resections are followed by higher morbidity and mortality than D1 resections, and offer no survival benefit over D1 procedures.5., 6.
The disadvantages of D2 resections have been mostly related to pancreatico-splenectomy, which had been described as an integral part of D2 gastrectomy for all proximal tumours by the JRSGC until the 1990s, and consequently was routinely adopted for middle and upper third tumours in the D2 arm of European trials.7
Unlike these two European trials, we have recently shown that D2 dissection with pancreas preservation is safe in a one-arm phase I–II trial with a very strict quality control system.8
There is not yet evidence from randomised controlled trials that D2 resections give better long-term survival results than standard D1. For this reason our new IGCSG phase III multicentre randomised trial was set up involving the same centres that had already participated into the previous phase 1–2 trial, in order to maintain a homogeneous level of experience among all surgeons.
Section snippets
Goals of the trial
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To evaluate whether extending the lymph node dissection to N2 level can improve the survival rate.
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To evaluate whether extending the lymph node dissection to N2 level can decrease the recurrence rate.
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To evaluate morbidity and mortality rates after surgery in both groups of patients.
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To determine the prognostic value of D2 dissection.
Patient selection
Patients less than 80-year-old with histologically proven and potentially curable gastric cancer were eligible for enrolment in the IGCSG trial. Patients undergoing
Results
From January 1999 to December 2002, 296 patients were registered from five participating centres out of the nine centres which participated in our previous trial. Of these, 134 were found not to be eligible for randomisation. Causes of non-eligibility are shown in Table 1. One hundred and sixty-two patients were randomised either to D1 (76) or D2 (86). The two groups were comparable with respect to median age, sex and location of the tumour, as reported in Table 2. They were also similar as
Discussion
Despite its recent decline, gastric cancer is still a common lethal disease in western countries. For apparently resectable cancers, surgery offers the best loco regional control; but unfortunately, average 5-year survival rates for treated patients remain low in the western world, ranging from 15 to 30%.11., 13. Over the years, Japanese surgeons have performed radical procedures involving extended lymphadenectomy, and have reported impressive survival figures with extremely low morbidity and
Acknowledgements
The authors thank Mr Peter McCulloch, Reader in Surgery at the University of Liverpool, UK, for help in editing and revising the manuscript.
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Cited by (0)
- ☆
For the IGCSG (T. Allone, D. Andreone, M. Calgaro, F. Calvo, L. Capussotti, M. Degiuli, G. R. Fronda, M. Garino, L. Locatelli, P. Mello Teggia, M. Morino, A. Ponti, F. Robecchi, D. Scaglione)