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

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).

ANTECEDENTES: El beneficio oncológico de la linfadenectomía extendida en el cáncer colorrectal es controvertido. Este ensayo clínico aleatorizado multicéntrico tuvo como objetivo abordar esta discrepancia. MÉTODOS: Se analizaron los datos de los primeros 100 pacientes aleatorizados en un ensayo en curso para evaluar la seguridad de la disección D3. Los pacientes con cáncer de colon primario resecable incluidos en 4 hospitales participantes en el ensayo COLD, se aleatorizaron para la disección D2 y D3 en una proporción 1: 1. RESULTADOS: Se incluyeron 99 pacientes en el análisis por intención de tratamiento (intention-to-treat, ITT) (43 en D2, 56 en D3). Un total de 92 pacientes recibieron el tratamiento asignado y se incluyeron en el análisis por protocolo (per-protocol, PP): 90,7% (39 de 43) en D2, 94,6% (53 de 56) en D3. No hubo mortalidad. La morbilidad postoperatoria a los 30 días fue del 46,5% en el grupo D2 y del 48,2% en el grupo D3 con un riesgo relativo (RR) de 1,04 (i.c. del 95%: 0,68 a 1,58), P = 0,86. Hubo dos casos de fuga anastomótica (4,7%) en el grupo D2 y ninguna en D3. La recuperación postoperatoria, las complicaciones y las tasas de reingreso no difirieron entre los análisis ITT y PP. El recuento medio de ganglios linfáticos fue 26,6 y 27,8 en D2 y D3, respectivamente. Se observó una resección completa del mesorrecto de buena calidad con mayor frecuencia en el grupo D3 (P = 0,048). En el grupo D3, 3 pacientes (5,4%) tenían metástasis en los ganglios linfáticos D3. D3 nunca fue el único nivel afectado de ganglios linfáticos. El estadio pN positivo fue más frecuente en el grupo D3: 46,4% versus 25,6% en D2, con un RR para revelar enfermedad N positiva de 1,81 (i.c. del 95% 1,01 a 3,2), P = 0,04. CONCLUSIÓN: La disección de ganglios linfáticos D3 es factible y puede estar asociada con una mejor estadificación N.

[Conversion of laparoscopic access in colorectal cancer surgery (in Russian only)]. / Konversiia laparoskopicheskogo dostupa v khirurgii kolorektal'nogo raka.

AIM: To analyze the problem of access conversion in laparoscopic surgery for colorectal cancer. MATERIAL AND METHODS: There were 876 procedures for colorectal cancer T14N01M0 performed at the Rostov Research Institute of Oncology in 2015-2017. Open and laparoscopic surgery was applied in 562 and 309 patients, respectively. Conversion of laparoscopic procedures was required in 35 (10.2%) patients. RESULTS: Conversions were 2.7 times more frequent in men (p<0.05) (probably due to anatomical features - a narrow pelvis) and predominantly with rectosigmoid (22.2%, 2 patients) and rectal cancer (12%, 22 patients). Conversions in women were as well in right-sided colon cancer (9.7%, 3 cases) and sigmoid cancer (7.4%, 4 patients). Conversions were performed mostly due to locally advanced tumors (37.1%, 13 patients) which are especially baffling in case of narrow pelvis. Visceral obesity (20%, 7 patients) and abdominal adhesions (17.1%, 6 patients) were also important causes of conversions. Conversions did not affect time of surgery (256 min vs. 240 min in laparoscopic and 237 min in open surgery). Intraoperative blood loss (284 ml) was higher than in laparoscopy (240 ml) but did not exceed that in open surgery (291 ml). CONCLUSION: It is necessary to assess risks and benefits of laparoscopy in patients with high probability of conversion in colorectal cancer surgery.

[Multiple primary colorectal cancer: Clinical aspects]. / Pervichno-mnozhestvennyi kolorektal'nyi rak: klinicheskie aspekty.

AIM: to define some clinical characteristics of synchronous and metachronous colorectal cancer (CRC). MATERIAL AND METHODS: The investigation was concerned with the data of 150 patients with T1-4N0-2M0-1 multiple primary CRC. The clinical, biological, and morphological characteristics of synchronous and metachronous tumors were analyzed. RESULTS: Multiple primary tumors were 6.01% of all the cases of CRC. There was a preponderance of synchronous CRC (63.75%) with the tumor localized in the sigmoid colon and rectum. In women, synchronous colorectal tumors were more often concurrent with breast tumors; metachronous ones were detected after treatment for genital tumors. In men, synchronous colorectal tumors were more frequently concurrent with kidney cancer; metachronous ones were identified after treatment for gastric cancer. CONCLUSION: The found characteristics of multiple primary colorectal tumors may be taken in account in programs for both primary diagnosis and follow-up after treatment for malignant tumors, which will be able to improve the early detection of cancer patients and their treatment results.