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Randomized Controlled Trial to Evaluate High Tie Versus Low Tie of the Inferior Mesenteric Artery in Anterior Resection

4 de agosto de 2013 actualizado por: Shoichi Fujii, MD, PhD

Randomized Controlled Trial to Evaluate High Tie Versus Low Tie of the Inferior Mesenteric Artery in Rectal Anterior Resection for Rectal Cancer Patients

The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is performed in practice. However, there is no evidence that shows effectiveness of this technique.

We conducted a randomized trial that compared between high tie and low tie of the IMA in rectal anterior resection to define an appropriate portion of IMA tying.

Descripción general del estudio

Descripción detallada

Patients

  • This was a randomized controlled trial conducted at a single institute, which was Yokohama City University Medical Center (Japan).
  • 300 patients who underwent anterior resection for rectal cancer were randomly allocated to receive high tie or low tie of the inferior mesenteric artery.

Surgical procedures

  • All surgical procedures were performed by one specialized colorectal treatment team. The laparoscopic surgeries were performed by a surgeon who passed the skill accreditation system for laparoscopic gastroenterological surgery was established by the Japanese Society for Endoscopic Surgery (JSES), and all open surgeries were performed under the supervision of these skillful surgeons.
  • All operations were performed according to the standard radical cure procedure described in the seventh edition of the Japanese General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus. That is, intestinal excision with lymph node dissection around the IMA at its origin was performed in all surgical procedures. Patients who underwent palliative partial excision were not included.
  • In the high tie (HT) of the IMA, IMA was separated at its origin from the abdominal aorta.
  • In the low tie (LT) of the IMA, IMA was separated after branching to the left colic artery. The lymph node dissection around the IMA at its origin was performed.

Randomization - To balance the operative backgrounds between HT and LT groups, the patients were stratified by the approach of surgery (open or laparoscopic surgery).

Adjuvant therapy

  • When the pathological stage was diagnosed as stage 3 by histological examination of the resected specimen, adjuvant chemotherapy was done with oral fluoropyrimidine anti-cancer drug.
  • Neither radiation therapy nor preoperative chemotherapy was given to any patient. Preoperative chemo-radiotherapy even for rectal cancer is not yet standard treatment in Japan.

Assessment parameters

  • The preoperative parameters
  • Operative assessment parameters
  • Postoperative assessment parameters An early postoperative complication was defined as a complication that occurred between the finish of the operation and postoperative day 30. A late postoperative complication was defined as a complication that occurred after postoperative day 30. The terminologies of complications were classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and grading was done by Classification of Surgical Complication.
  • The pathological results were recorded according to the 7th edition of the Japanese General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus and 7th edition of primary tumor, regional nodes, metastasis (TNM) classification. Circumferential margin involvement was defined as exposure of a cancer cell at the vertical dissection surface on histological examination.

Follow-up schedule

- The follow-up schedule was as follows according to stage. Patients with stages 0 and 1 were followed up with outpatient examinations including tumor marker measurements, and chest, abdominal and pelvic computed tomography (CT) once a year for five years. Patients with stage 2 and 3a were examined by CT and tumor marker measurements every six months for the first two years. These examinations were done once a year from the third year to the fifth year. Patients with stage 3b and 3c were examined by CT and tumor marker measurements every four months for the first two years, and every six months from the third year to the fifth year.

Statistical analysis

  • The primary endpoint was anastomotic leakage rate.
  • The secondary endpoints were operation time, amount of bleeding and 5-year overall survival. To evaluate whether a difference in the operative procedure influences survival including death due to another disease, a comparison of overall survival has meaning. Operation time and amount of bleeding were added to the secondary endpoints because these parameters had a possibility of becoming grounds of selection of the operation method if there were no differences in overall survival.
  • A sample size of 284 patients was assured to achieve a power of 70% to detect a difference between the groups using a two-sided Chi-squared test with type I error rate equal to 0.05, when the true complication rates were 4% and 12% for the LT and HT groups, respectively. A sample size of 300 patients was assured to achieve a power of 73% to detect a difference in a same condition. The dropouts were considered and the number of accumulation targets was assumed to be 300 patients to keep a power of more than 70%.
  • For continuous variables, data are presented as means ± standard deviation (SD). For categorical variables, data are presented as frequencies and percentages (%). Comparison of the endpoints was based on intention-to-treat principle, that is, the patients who switched to another group during surgery were treated as members of the allocated group. The Chi-squared test was applied to evaluate the significance of differences in proportions, and t-test was used to evaluate the significance of differences in continuous variables. A p-value of less than 0.05 was considered to be statistically significant.

Tipo de estudio

Intervencionista

Inscripción (Actual)

331

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Kanagawa-ken
      • Yokohama, Kanagawa-ken, Japón, 232-0024
        • Yokohama City University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age of 20 years old or over
  • Anterior resection is scheduled for rectal cancer and rectosigmoid cancer preoperatively.
  • Histologically proven adenocarcinoma
  • Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
  • Elective operation
  • Tolerable surgery under general anesthesia
  • No history of laparotomy for colorectal resection except appendectomy
  • Provided written informed consent

Exclusion Criteria:

  • Synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
  • Multiple colorectal cancer that needs reconstruction two or more times
  • Acute intestinal obstruction or perforation due to rectal cancer
  • Pregnant or lactating women

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: High tie of IMA
In High tie group, IMA was transected at its origin from the abdominal aorta.
Conventional technique
Otros nombres:
  • High tie
Experimental: Low tie of IMA
In the low tie of the IMA, IMA was separated after branching to the left colic artery. The lymph node dissection around the IMA at its origin was performed.
Technique for preserving left colic arterial perfusion
Otros nombres:
  • Low tie

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anastomotic leakage rate
Periodo de tiempo: 14 days after surgery
Anastomotic leakage rate is defined as an incontinuity at the anastomosis using circular stapler.
14 days after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sobrevivencia promedio
Periodo de tiempo: 5 años
Toda muerte se define como un evento de supervivencia global.
5 años
Operation time
Periodo de tiempo: 1 day after surgery
1 day after surgery
Amount of blood loss
Periodo de tiempo: 1 day after surgery
1 day after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Chikara Kunisaki, Professor, Yokohama City University, Gastroenterological Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2006

Finalización primaria (Actual)

1 de septiembre de 2012

Finalización del estudio (Anticipado)

1 de septiembre de 2017

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2013

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2013

Publicado por primera vez (Estimar)

23 de mayo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de agosto de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

4 de agosto de 2013

Última verificación

1 de agosto de 2013

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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