Morbidity and mortality after D1 and D2 gastrectomy for cancer: Interim analysis of the Italian Gastric Cancer Study Group (IGCSG) randomised surgical trial

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Abstract

Background. The disadvantages of D2 gastrectomy have been mostly related to splenopancreatectomy. Unlike two large European trials, we have recently showed the safety of D2 dissection with pancreas preservation in a one-arm phase I–II trial. This new randomised trial was set up to compare post-operative morbidity and mortality and survival after D1 and D2 gastrectomy among the same experienced centres that participated into the previous trial.

Methods. In a prospective multicenter randomised trial, D1 gastrectomy was compared to D2 gastrectomy. Central randomisation was performed following a staging laparotomy in 162 patients with potentially curable gastric cancer.

Findings. Of 162 patients randomised, 76 were allocated to D1 and 86 to D2 gastrectomy. The two groups were comparable for age, sex, site, TNM stage of tumours, and type of resection performed. The overall post-operative morbidity rate was 13.6%. Complications developed in 10.5% of patients after D1 and in 16.3% of patients after D2 gastrectomy. This difference was not statistically significant (p<0.29). Reoperation rate was 3.4% after D2 and 2.6% after D1 resection. Post-operative mortality rate was 0.6% (one death); it was 1.3% after D1 and 0% after D2 gastrectomy.

Interpretation. Our preliminary data confirm that in very experienced centres morbidity and mortality after extended gastrectomy can be as low as those showed by Japanese authors. They also suggest that D2 gastrectomies with pancreas preservation are not followed by significantly higher morbidity and mortality than D1 resections.

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

  • To evaluate whether extending the lymph node dissection to N2 level can improve the survival rate.

  • To evaluate whether extending the lymph node dissection to N2 level can decrease the recurrence rate.

  • To evaluate morbidity and mortality rates after surgery in both groups of patients.

  • 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)

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