The paitents with peritoneal metastasis of pancreatic cancer who received CRS + HIPEC were enrolled at Department of Peritoneal Cancer, Beijing shijitan Hospital, between March 2017 and December 2023. Synchronous peritoneal metastasis was identified by the simultaneous detection of pancreatic cancer and peritoneal metastasis, whereas metachronous peritoneal metastasis was characterized by the occurrence of peritoneal metastasis following pancreatectomy. The research methodology strictly adhered to the ethical guidelines stipulated by the institutional review board, and was consistent with the principles of the 1964 Helsinki Declaration and its subsequent amendments. Approval for the study was granted by the Ethics Committee of Beijing Shijitan Hospital. Written informed consent was obtained from all participants prior to their undergoing CRS + HIPEC, following a detailed explanation of the procedure and its potential risks.
Inclusion criteria
The decision to pursue CRS combined HIPEC for pancreatic cancer with peritoneal metastasis was informed by a preoperative set of inclusion criteria established to identify candidates who may benefit from this aggressive therapeutic strategy, despite it not being the standard care for this patient cohort. The criteria encompassed: (1) A confirmed diagnosis of pancreatic cancer with biopsy-confirmed or frozen pathology-verified peritoneal metastasis; (2) Assessment of disease extent via imaging modalities, such as computed tomography (CT) or positron emission tomography (PET), suggesting that the peritoneal metastases were potentially resectable; (3) Evaluation of the patient’s overall health and performance status, ensuring suitability for enduring major surgery and its associated risks; (4) Adequate organ function, as determined by laboratory testing, to withstand the potential impact of the procedure; (5) Consensus among a multidisciplinary team, including hepatobiliary and gastrointestinal surgeons, medical oncologists, radiologists, and pathologists, that the patient would likely derive benefit from the CRS + HIPEC approach; and (6) The patient’s informed consent, which entailed an extensive discussion of the procedure’s risks, benefits, and available alternative treatments.
Procedure of CRS + HIPEC
The CRS + HIPEC procedure involved: (1)Surgical approach: an open abdominal method was adopted for CRS, followed by HIPEC. (2) Tumor burden evaluation: the Peritoneal Cancer Index (PCI) was calculated intraoperatively in accordance with the method described by Sugarbaker, ranging from 0 ~ 39 [17]. (3) Tumor removal: all macroscopically visible tumors, including those involving the viscera and peritoneum affected by carcinomatosis, were resected maximally. The organ resections incorporated procedures on the ascending colon, transverse colon, descending colon, sigmoid colon, complete colon, gastrectomy, small intestine resection, rectal resection, and excision of the ovaries and fallopian tubes, hysterectomy, partial hysterectomy, kidney, and spleen, pancreas, gallbladder, and bladder. The peritonectomy encompassed the bilateral diaphragmatic peritoneum, greater and lesser omentum, bilateral colonic sulcus peritoneum, hepatic round ligament, anterior wall peritoneum, pelvic floor peritoneum, and mesentery. (4) HIPEC Administration: Following the CRS, HIPEC was administered using a combination of docetaxel (120 mg) and cisplatin (120 mg) for a duration of 30 to 60 min. (5) Digestive tract reconstruction: following CRS + HIPEC, digestive tract reconstruction was undertaken. (6) Cytoreduction completeness assessment: the extent of cytoreduction was evaluated based on the size of residual nodules: CC-0 indicated no visible nodules; CC-1, residual nodules smaller than 2.5 mm; CC-2, nodules measuring 2.5 mm to 2.5 cm; and CC-3, nodules larger than 2.5 cm.
Study endpoints and definitions
Collected clinical data included parameters such as gender, age, Body Mass Index (BMI), Karnofsky Performance Score (KPS). Detailed information pertaining to CRS + HIPEC encompassed operation duration, organ resections, peritoneum resection, anastomosis procedures, specifics of HIPEC administration, PCI score, CC score, and the requirement for blood transfusions, as well as related preoperative and postoperative treatments.
Postoperative complications were graded according to the Clavien-Dindo Classification System, which comprises nine categories with forty-eight adverse events distributed across levels I to IV. Complications at levels III to IV were defined as severe adverse events (SAEs) [18]. Outcome measures were OS, defined as the time from the date of CRS + HIPEC to the last follow-up or death.
Statistical analysis
All statistical evaluations were conducted employing the SPSS (version 26.0, IBM, Chicago). We opted for the utilization of non-parametric methodologies for the meticulous analysis of the data. OS was analyzed utilizing Kaplan-Meier estimates, with survival curves being determined through the application of the log-rank test. Hazard ratios and P-values were calculated using the Cox proportional hazards model.
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