A Trial to Evaluate Para-Aortic Lymphadenectomy for Gastric Cancer

• relapse-free survival
• operative morbidity and mortality
• length of postoperative hospital stay
• quality of life

To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.

• Procedure: Surgery: D2 dissection
• Procedure: Surgery: D2+paraaortic dissection

• Sano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004 Jul 15;22(14):2767-73. Epub 2004 Jun 15.
• Kurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45.
• Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62.

Inclusion Criteria:

- Preoperatively,

1. histologically proven adenocarcinoma
2. 75 years old or younger
3. forced expiratory volume in one second ≥ 50 %
4. arterial oxygen pressure in room air ≥ 70 mmHg
5. creatinine clearance ≥ 50 ml/min
6. written consent. Intraoperatively
7. Macroscopic T staging is T2-subserosa, T3, or T4
8. potentially curative operation is possible
9. no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed)
10. peritoneal lavage cytology is negative for cancer cells

Exclusion Criteria:

1. Carcinoma in the remnant stomach
2. Borrmann type 4 (linitis plastica)
3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
4. past history of myocardial infarction or positive results of exercise ECG
5. liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%