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.
Analysis of short‐term outcomes of the first 100 patients enrolled in the COLD trial comparing D2 and D3 lymph node dissection for colonic cancer did not reveal any increase in morbidity or mortality in D3. N‐positive status was more frequent in the D3 group.
Better nodal staging
Background
The extent of lymph node dissection in colonic cancer surgery remains arguable, and evidence from RCTs regarding extended lymph node dissection outcomes is lacking. This study aimed to ...compare the long‐term results of D3 lymph node dissection with those of D2 dissection.
Methods
This is a multicentre RCT. The aim is to enrol 768 patients with primary colonic cancer assigned randomly to D2 or D3 lymph node dissection. The trial is assessing the superiority of 5‐year overall survival as the primary endpoint in patients undergoing D3 lymph node dissection versus D2 dissection. Secondary endpoints include disease‐free survival, short‐term outcomes (30‐day morbidity and mortality), quality of complete mesocolic excision and lymph node dissection, pattern of lymph node metastasis and quality of life in patients following D2 and D3 lymph node dissection. Experience of 20 D3 and 20 D2 lymph node dissections is required for surgeons to participate in the trial. For surgical accreditation four non‐edited videos of procedures will be assessed. Patients will be followed up for 5 years after last patient enrolment. Intention‐to‐treat analysis will be performed.
Discussion
The results of this study will demonstrate whether extended lymph node dissection is superior to standard dissection in terms of oncological outcomes, and will also assess the impact of more extensive surgery on short‐term outcomes and quality of life.
Protocol for a randomized clinical trial evaluating long‐term outcomes of D3 versus D2 lymph node dissection for colonic cancer.
A trial to evaluate the extent of surgery
Anastomotic leakage after surgery for colorectal cancer is a widely known factor aggravating immediate outcomes. At the same time, deterioration of oncological results is under much less attention. ...Long-term consequences of anastomotic leakage and possible mechanism of negative effect of this complication on long-term results are reviewed in the article.
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