Comparison of the Resection Site Order in Simultaneous Approach of Colorectal Liver Metastasis

Официальное название

Comparison of the Resection Site Order in Simultaneous Approach of Colorectal Liver Metastasis. An International Multicentric Retrospective Trial.

Обзор

Colorectal cancer frequently presents with liver metastases, and complete removal of both primary and liver tumors can significantly improve survival. Simultaneous resection (SA) of the colon and liver is increasingly used and is considered safe when minor liver resections are performed, offering advantages such as shorter hospitalization, fewer complications, and faster chemotherapy initiation. However, the best sequence of resection, liver-first or colon-first, remains uncertain, as each has potential benefits and drawbacks, particularly regarding anastomotic healing. Minimally invasive approaches to SA show similar outcomes to open surgery, though limited data suggest that resection order may affect blood loss.

Подробное описание

Colorectal cancer is the third most common cancer worldwide, and 15-25% of patients present with liver metastases at diagnosis. Complete resection of both the primary tumor and liver metastases can yield survival rates up to 47.9%. Simultaneous resection (SA) of the colon and liver is a potential option for patients with synchronous metastases, though traditionally considered high-risk, especially when major hepatectomies are involved.

Recent studies show that SA is safe when minor hepatectomies are paired with standard colon resections and may offer advantages such as reduced hospital stay, lower costs, fewer complications, and faster initiation of chemotherapy.

The optimal sequence of resection in SA remains unclear. Liver-first procedures may preserve sterility and address the prognostically significant lesion first but could impair bowel anastomosis healing.

Minimally invasive surgery (MIS), including laparoscopic and robotic approaches, is increasingly used for SA and appears comparable to open surgery in terms of morbidity, mortality, and oncologic outcomes. Early data on MIS suggest that resection order may influence intraoperative blood loss, but findings remain inconsistent and require further investigation.

Вмешательства

• Процедура Data collection
  Data collection to assess whether the order of resection of the site in a simultaneous approach (liver first vs. colon first) in colorectal cancer with liver metastases affects overall postoperative morbidity.

Первичные конечные точки

• Difference in overall morbidity rates [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (5)

• Mortality [Срок оценки: Through study completion, an average of 1 year]
• Overall survival [Срок оценки: Through study completion, an average of 1 year]
• Disease-free survival [Срок оценки: Through study completion, an average of 1 year]
• Recurrence sites [Срок оценки: Through study completion, an average of 1 year]
• Morbidity [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Adult patients diagnosed with colorectal cancer with synchronous liver metastases during the reference period, who underwent simultaneous resection.

Критерии исключения

• Simultaneous emergency resection due to symptoms of the primary tumor.
• Presence of extrahepatic metastatic disease confirmed at the time of resection or diagnosis.
• High surgical risk defined as an ASA risk score greater than 3.
• At least 10 cases performed by the invited center during the study period.
• Incomplete data or follow-up of less than 6 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• SC Chirurgia Generale — Alessandria

Идентификаторы

NCT: NCT07272928 · ASO.ChirGen.24.06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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