Dissemination of tumor cells during minimally invasive and open pancreatic cancer surgery

Phase 2

Recruiting

Conditions: C25
Malignant neoplasm of pancreas

Registration Number: DRKS00022026

Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

newly diagnosed, resectable or borderline resectable1 pancreatic cancer without arterial involvement, on cross-sectional imaging (contrast enhanced CT scan) according to the International Study Group of Pancreatic Surgery (ISGPS) criteria; =18 and =85 years of age; capacity to informed consent; written informed consent; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; patient considered to tolerate surgery

Exclusion Criteria

distant metastatic disease; neoadjuvant chemotherapy/radiotherapy; American Society of Anesthesiologists (ASA) score > III; history of another malignancy in the past 5 years; inability to comply with study and/or follow-up procedures; (language) problems in understanding the patient information document explaining the present clinical trial; any condition which could result in an undue risk for the patient in the opinion of the investigator

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative tumor cell dissemination - circulating tumor cells (CTCs) and disseminated tumor cells (DTCs)

Secondary Outcome Measures

Name	Time	Method
30-and 60-day complication rate according to the Clavien-Dindo classification; 30-and 60-day mortality; pancreas-associated postoperative morbidity: postoperative pancreatic fistula (POPF), intraabdominal fluid-collection or abscess, delayed gastric emptying and postpancreatectomy hemorrhage; bile leakage; chyle leakage; Duration of surgery; Intraoperative blood loss; Conversion rate of minimally invasive procedures; Resection margin status; Number of resected lymph nodes and number of tumor-positive lymph nodes; duration of intensive care unit stay (postoperative and readmissions); postoperative duration of hospital stay, need and reason for readmission; anemia (Hb < 8 g/dl), thrombocytopenia, leukopenia; postoperative sepsis; renal failure (serum creatinine, BUN, urine production); liver damage (AST > 5 x ULN, ALT > 5 x ULN, AP > 5 x ULN, GGT, bilirubine > 1.5 x ULN); time to start adjuvant chemotherapy