1. Trials in gastric cancer surgery Presenter Dr Pankaj Kumar Garg Moderator Dr Sunil Kumar

2. Learning objectives Extent of Gastric resection Extent of Lymphadenectomy Omentectomy Bursectomy Laparoscopic gastric cancer surgery Nasogastric drainage Surgical Site infection prophylaxis Intraperitoneal drain placement

3. EXTENT OF GASTRECTOMY

4. Extent of Gastrectomy Types of Gastric resections 1.Total gastrectomy 2.Distal gastrectomy 3.Pylorus preserving gastrectomy 4.Segmental gastrectomy 5.Local resections

5. Resection line decided by – T1 tumors 2 cm – T2 and deep tumors3 cm (Type 1 and 2) – T2 and deep tumors5 cm (Type 3 and 4) If these rules not followed – Frozen section

6. Distal tumorsDistal gastrectomy Proximal tumorsTotal gastrectomy Proximal tumorsNo RCT Distal tumorsThree RCTs

7. Distal Vs. Total gastrectomy Total patients randomized201 No difference in post operative morbidity (32 % vs 34%), No mortality in any group No difference in five year survival

8. Distal Vs. Total gastrectomy Total patients randomized55 Significant difference in post operative morbidity and mortality in TG group Median survival better in SG groups (1511 vs. 922 days, p < 0.05)

9. Distal Vs. Total gastrectomy Total patients randomized618 No difference in post operative morbidity and mortality in any group No difference in five year survival (65.3% vs 62.4%)

10. EXTENT OF LYMPHADENECTOMY

11. Extent of Lymphadenectomy D1 vs D2 Total patients randomized711 Significant difference in post operative morbidity (25% vs. 43%, P value < 0.001) and mortality (4% vs. 10%. P value < 0.001) No significant difference in 5 year survival (43% vs. 47%.) and local recurrence rate (43% vs. 37%)

13. Extent of Lymphadenectomy D1 vs D2 Total patients randomized711 No significant difference in 11 year survival (30% vs. 35%.)

14. Extent of Lymphadenectomy D1 vs D2 Overall 15-year survival 21% vs. 29% (p=0.34). Gastric-cancer-related death rate (48%, vs. 37%, 123 patients), Local recurrence 22% vs. 12% Regional recurrence was 19% versus 13%. Spleen-preserving D2 resection technique the recommended surgical approach

15. Patients 400 5-year survival rates were 35% for D1 resection and 33% for D2 resection (difference –2%, 95% CI = –12%–8%)

16. Flaws in the British and Dutch Trial No quality control surgery; Surgeon explained D2 dissection with videotapes and booklets. Involved many low volume centers doing a few gastric resections per year High non compliance Routine splenectomy and distal splenectomy in all D2 dissections, Also included pancreatectomy in many D2 dissections

19. In specialized centres, the rate of complications following D2 dissection is much lower than in published randomized Western trials.

20. Extent of Lymphadenectomy D1 Vs D3 Wun wu et al, University of Taipei, Taiwan Patients 221 The average number of lymph nodes removed was 42.7 in D2 and 68.7 in D3 Overall 5-year survival significantly higher in D3 surgery than in D1 surgery (59·5% vs 53·6%). 215 R0 resection patients : recurrence of 50·6% for D1 and 40·3% for D3 at 5 years

21. Extent of Lymphadenectomy D2 Vs D2+ Yonemura et al, Shizuoka Cancer Center, Japan Patients 293 The average number of lymph nodes removed was 42.7 in D2 and 68.7 in D2+ Five-year survival was 52.6% for the 135 D2 dissection and 55.0% for D2+dissection. Prophylactic D4 dissection not recommended for patients with potentially curable advanced gastric cancer.

22. Patients 523 No significant differences between the two groups in the frequencies of anastomotic leakage, pancreatic fistula, abdominal abscess, pneumonia, or death from any cause within 30 days after surgery

23. Minimally invasive gastric surgery

24. Ming Cui et al. Peking University Cancer Hospital and Institute, Beijing, China Patients 209

26. Laparoscopic D2 dissection is equivalent to OG in the number of HLNs, regardless of tumor location. Thus, this procedure can achieve the same radicalness as OG.

27. Omentectomy

28. Planned sample size: 250 AIM: To evaluate the impact of omentectomy for advanced gastric cancer on patient survival. Endpoint: 3-year relapse-free survival rate

29. BURSECTOMY

30. Imamura et al. Sakai, Japan.

31. Experienced surgeons could safely perform a D2 gastrectomy with an additional bursectomy without increased major surgical complications.

32. Fuzita et al, Osaka, Japan Patients: 210 patients with cT2–T3 No difference in Morbidity and mortality 3-year OS rates 85.6% in the bursectomy group and 79.6% in the non-bursectomy group Among 48 serosa-positive (pT3–T4), the 3- year OS was 69.8% for the bursectomy group and 50.2% for the non-bursectomy group.

33. INTRAPERITONEAL DRAINAGE

34. Intraperitoneal drainage Patients 170 Procedure: Subtotal or total gastrectomy with D2 dissection No difference in postoperative complications

35. Intraperitoneal drainage Patients 60 Procedure: Total gastrectomy with D2 dissection Postoperative morbidity, hospital stay significantly higher in patients with drains

36. NASOJEJUNAL DECOMPRESSION

37. Nasojejunal decompression Patients: 237 Procedure Total gastrectomy No difference in anastomotic leak, postoperative morbidity and mortality Major postoperative complications (25.9% and 21.5%, P=.42) Overall postoperative mortality (0.9% and 0.8%, respectively; P=.50

38. SURGICAL SITE PROPHYLAXIS

39. Surgical site infection prophylaxis Patients: 501 Procedure: Gastric cancer surgery SSI rate was 9·5 per cent (23 of 243) and 8·6 per cent (21 of 243) Antimicrobial prophylaxis had no major adverse effects.

40. Current evidence Spleen preserving D2 dissection is the standard of care for T2-4 gastric cancer Complete bursectomy is likely to improve survival and to decrease in local recurrence in advanced gastric cancer. No role of routine intra-peritoneal drainage and naso-jejunal drainage. Single dose anti-microbial prophylaxis seems sufficient.