Nodal dissection for patients with gastric cancer: a randomised controlled trial

Summary

Background

The survival benefit and morbidity after nodal dissection for gastric cancer remains controversial. We aimed to do a single-institution randomised trial to compare D1 (ie, level 1) lymphadenectomy with that of D3 (ie, levels 1, 2, and 3) dissection for gastric cancer in terms of overall survival and disease-free survival.

Methods

From Oct 7, 1993, to Aug 12, 1999, 335 patients were registered. 221 patients were eligible, 110 of whom were randomly assigned D1 surgery and 111 of whom were randomly assigned D3 surgery, both with curative intent. Three participating surgeons had done at least 25 independent D3 dissections before the start of the trial, and every procedure was verified by pathological analyses. The primary endpoints were 5-year overall survival and 5-year disease-free survival. We also analysed risk of recurrence. Main analyses were done by intention to treat. This trial is registered at the US National Institute of Health website http://www.clinicaltrials.gov/ct/show/NCT00260884.

Findings

Median follow-up for the 110 (50%) survivors was 94·5 months (range 62·9–135·1). Overall 5-year survival was significantly higher in patients assigned D3 surgery than in those assigned D1 surgery (59·5% [95% CI 50·3–68·7] vs 53·6% [44·2–63·0]; difference beteween groups 5·9% [−7·3 to 19·1], log-rank p=0·041). 215 patients who had R0 resection (ie, no microscopic evidence of residual disease) had recurrence at 5 years of 50·6% [41·1–60·2] for D1 surgery and 40·3% [30·9–49·7] for D3 surgery (difference between groups 10·3% [−3·2 to 23·7], log-rank p=0·197).

Interpretation

D3 nodal dissection, compared with that of D1, offers a survival benefit for patients with gastric cancer when done by well trained, experienced surgeons.

Introduction

At present, surgical resection is the treatment of choice for gastric cancer. However, the need for radical lymph-node dissection for curative treatment of gastric cancer continues to be debated. Many surgeons do minimum (ie, D1 or level 1 lymphadenectomy) or no lymph-node dissection. Retrospective studies1, 2 from several centres in Japan, Europe, and USA have reported improved survival for patients who underwent D3 (ie, levels 1, 2, and 3 on first edition of Japanese classification of gastric cancer³) lymphadenectomy on gastric resection. Two large randomised trials4, 5 from the Netherlands⁴ and the UK⁵ have shown no survival benefits, but high morbidity (43–46%) and mortality (10–13%), after D3 (ie, D2 on second edition of Japanese classification of gastric cancer⁶) gastric dissection compared with D1 dissection. These trials4, 5 were multi-institutional, had difficulty in ensuring quality control, and had many participating surgeons with little or no experience in D3 dissection. For a surgical trial to compare meaningfully different operative methods, perhaps participating surgeons should be equally experienced in both techniques.

In Taiwan, gastric cancer is the fifth most common cause of death from cancer. Surgical resection does or does not include wide lymphadenectomy (ie, D2 or D3 resection). We aimed to do a prospective, randomised comparison of D1 and D3 dissection at a single institution, focusing on advanced gastric cancer (ie, invasion beyond the submucosa) because of its high frequency of lymph-node metastasis.⁷ Data reported previously⁸ from our trial found that: short-term morbidity was higher in patients assigned D3 dissection compared with those assigned D1; there were no deaths in either group within 30 days of surgery; and that D3 dissection was associated with more complications, blood loss, operation time, and a longer hospital stay than was D1 dissection. Here, we report the long-term survival data and the cumulative risk of recurrence for these two surgical groups.