Laparoscopic advanced intraoperative restaging for radiographic non-metastasis pancreatic cancer: Protocol for a single-center, cross-sectional and follow-up study

BACKGROUND: Although surgical resection holds promise for curing pancreatic cancer, <20% of patients are suitable; however, early postoperative recurrence is common. Currently, radiographic examination is the primary method to determine whether pancreatic cancer has metastasized and to inform clinical staging before surgery. However, the method has a limited detection rate for micro-metastasis within the abdominal cavity; therefore, patients with advanced pancreatic cancer and existing micro-metastasis may receive unnecessary surgical treatment, delaying the timing of adjuvant chemotherapy and resulting in poor prognosis. Laparoscopic staging might be used as a supplement to detect micro-metastasis in patients with pancreatic cancer; however, there is no consistent standard to guide the use of this procedure. Therefore, it is necessary to conduct a trial to further explore the consistency and short-term and long-term efficacy of an intraoperative staging strategy for patients with radiographic non-metastasis. METHODS/DESIGN: This is a single-center cross-sectional and follow-up study. Patients diagnosed with pancreatic cancer without metastasis by radiographic examination and histopathological biopsy, who received intraoperative restaging, will be enrolled. The total sample size required for the trial is approximately 125 patients from May 2020 to December 2022. First, radiographic examination staging will be used. Then, laparoscopic exploration will be performed for patients without definite metastatic lesions. Data collection will include preoperative blood examination, radiographic examination, surgical information, and postoperative recovery. The patients will undergo follow-up every 3 months after surgery until death. The primary endpoint is the metastasis-positive rate via laparoscopic exploration. The secondary endpoints are the consistency, sensitivity, and specificity of the intraoperative restaging strategy and radiographic examination, the incidence of postoperative complications within 30 days, the 6-month relapse-free survival rate, and perioperative indicators (total cost, hospital stay, length of surgery, and intraoperative blood loss). DISCUSSION: We are conducting the trial to explore the metastasis-positive rate of intraoperative restaging strategy for diagnosing pancreatic cancer micro-metastasis. This new intraoperative restaging strategy would help pancreatic cancer patients with potential micro-metastasis avoid receiving unnecessary resection, allow systemic treatment as early as possible, and improve the prognosis of patients.