Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial)

Author:

Karachun A1,Panaiotti L1,Chernikovskiy I23,Achkasov S4,Gevorkyan Y5,Savanovich N23,Sharygin G2,Markushin L23,Sushkov O4,Aleshin D6,Shakhmatov D4,Nazarov I4,Muratov I4,Maynovskaya O7,Olkina A1,Lankov T1,Ovchinnikova T8,Kharagezov D5,Kaymakchi D5,Milakin A5,Petrov A1ORCID

Affiliation:

1. Surgical Department of Abdominal Oncology, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia

2. Clinical Research Centre of Specialized Kinds of Medical Care (Oncology), Saint Petersburg, Russia

3. City Oncology Hospital No. 62, Moscow, Russia

4. Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia

5. Rostov Research Institute of Oncology, Rostov-on-Don, Russia

6. Operational Unit, Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia

7. Pathology Department, State Scientific Centre of Coloproctology, Moscow, Russia

8. Pathology Department, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia

Abstract

Abstract Background It remains unclear whether extended lymphadenectomy provides oncological advantages in colorectal cancer. This multicentre RCT aimed to address this issue. Methods Patients with resectable primary colonic cancer were enrolled in four hospitals registered in the COLD trial, and randomized to D2 or D3 dissection in a 1 : 1 ratio. Data were analysed to assess the safety of D3 dissection. Results The study included the first 100 patients randomized in this ongoing trial. Ninety-nine patients were included in the intention-to-treat (ITT) analysis (43 D2, 56 D3). Ninety-two patients received the allocated treatment and were included in the per-protocol (PP) analysis: 39 of 43 in the D2 group and 53 of 56 in the D3 group. There were no deaths. The 30-day postoperative morbidity rate was 47 per cent in the D2 group and 48 per cent in the D3 group, with a risk ratio of 1·04 (95 per cent c.i. 0·68 to 1·58) (P = 0·867). There were two anastomotic leaks (5 per cent) in the D2 group and none in the D3 group. Postoperative recovery, complication and readmission rates did not differ between the groups in ITT and PP analyses. Mean lymph node yield was 26·6 and 27·8 in D2 and D3 procedures respectively. Good quality of complete mesocolic excision was more frequently noted in the D3 group (P = 0·048). Three patients in the D3 group (5 per cent) had metastases in D3 lymph nodes. D3 was never the only affected level of lymph nodes. N-positive status was more common in the D3 group (46 per cent versus 26 per cent in D2), with a risk ratio of 1·81 (95 per cent c.i. 1·01 to 3·24) (P = 0·044). Conclusion D3 lymph node dissection is feasible and may be associated with better N staging. Registration number: NCT03009227 (http://www.clinicaltrials.gov).

Funder

N. N. Petrov National medical research centre of oncology

Publisher

Oxford University Press (OUP)

Subject

Surgery

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