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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022026

Enrollment

Registered

2020-05-25

Start date

2020-06-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C25

Interventions

Group 1: Minimally invasive (i.e. laparoscopic or robotic) pancreatic resection for pancreatic cancer (i.e. partial or total pancreatoduodenectomy, or distal pancreatectomy) Group 2: Open pancreatic r

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Perioperative tumor cell dissemination - circulating tumor cells (CTCs) and disseminated tumor cells (DTCs)	—

Secondary

Measure	Time frame
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 5 x ULN, ALT > 5 x ULN, AP > 5 x ULN, GGT, bilirubine > 1.5 x ULN); time to start adjuvant chemotherapy	—

Measure

Time frame

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 5 x ULN, ALT > 5 x ULN, AP > 5 x ULN, GGT, bilirubine > 1.5 x ULN); time to start adjuvant chemotherapy

—

Countries

Germany

Contacts

Public ContactSusanne Roth

Chirurgische Klinik, Abteilung für Allgemein-, Viszeral-und Transplantationschirurgie, Universitätsklinikum Heidelberg

Susanne.Roth@med.uni-heidelberg.de00496221565150

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026