Dissemination of tumor cells during minimally invasive and open pancreatic cancer surgery
Organizational Data
- DRKS-ID:
- DRKS00022026
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-05-25
- Last update in DRKS:
- 2022-06-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
Domino-Pac
URL of the study
No Entry
Brief summary in lay language
Pancreatic cancer is a particularly aggressive form of cancer with an exceptionally poor prognosis. The only treatment option with a chance of cure is the complete removal of a localised tumour with subsequent chemotherapy. However, long-term survival is still rare. The reason for this is the return or renewed growth of the tumour after surgical removal and the formation of metastases. The cause of tumour recurrence after surgical resection is only partially understood. It is assumed that pancreatic cancer forms tiny tumor metastases at an early stage and that tumor cells may also spread throughout the body during surgery. Tumor cells that spread through the blood entail that the goal of the operation, namely to remove as many malignant cells as possible, cannot be achieved. While open pancreas resection has been the standard procedure for years, minimally invasive surgical procedures have recently become increasingly common. However, it is unclear whether surgical resection techniques, especially minimally invasive and open procedures, influence tumor cell dissemination. The differences in surgical and oncological outcomes between minimally invasive and open procedures have also not been sufficiently investigated. Therefore, the primary purpose of the present study is to investigate tumor cell dissemination by surgical manipulation during minimally invasive and open procedures. The secondary objective is to investigate differences in peri- and postoperative outcomes.
Brief summary in scientific language
Pancreatic cancer is a particularly aggressive form of cancer, which is usually detected late, at an advanced stage. Despite tremendous research efforts, the prognosis of this disease is still very poor. The five-year survival rate is only about 9%. Complete resection of the primary tumor followed by adjuvant chemotherapy is the current standard treatment for patients with resectable disease and the only curative treatment option. However, even in these cases, the five-year survival rate is less than 20%. Although numerous studies have proven the efficacy of adjuvant chemotherapy in pancreatic cancer with prolonged survival, long-term survivors are still very rare. The dissemination of tumour cells through manipulation during surgery can increase the rate of future metastases and local recurrences. While open pancreas resection has been the standard procedure for years, minimally invasive surgery is becoming more and more common. Nevertheless, it is still uncertain whether surgical techniques for pancreatic cancer resection, in particular minimally invasive and open procedures, have an impact on tumor cell spread. In addition, possible differences in the oncological outcome between minimally invasive and open surgical procedures for pancreatic cancer have not been sufficiently investigated. In the present prospective, non-randomized, controlled, clinical pilot study, the scattering of tumor cells during tumor manipulation in minimally invasive and open surgical procedures will therefore be analyzed. Furthermore, possible differences in peri- and postoperative complications will be investigated.
Health condition or problem studied
- ICD10:
- C25 - Malignant neoplasm of pancreas
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Minimally invasive (i.e. laparoscopic or robotic) pancreatic resection for pancreatic cancer (i.e. partial or total pancreatoduodenectomy, or distal pancreatectomy)
- Arm 2:
- Open pancreatic resection for pancreatic cancer (i.e. partial or total pancreatoduodenectomy, or distal pancreatectomy)
Endpoints
- Primary outcome:
- Perioperative tumor cell dissemination - circulating tumor cells (CTCs) and disseminated tumor cells (DTCs)
- Secondary outcome:
- 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
Study Design
- Purpose:
- Prognosis
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Chirurgische Klinik Heidelberg
Recruitment period and number of participants
- Planned study start date:
- 2020-06-01
- Actual study start date:
- 2020-06-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 90
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 85 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum HeidelbergIm Neuenheimer Feld 67269120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-heidelberg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Chirurgische Klinik, Abteilung für Allgemein-, Viszeral-und Transplantationschirurgie, Universitätsklinikum HeidelbergPD Dr. Dr. Susanne RothIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- 00496221565150
- Fax:
- 00496221565969
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Chirurgische Klinik, Abteilung für Allgemein-, Viszeral-und Transplantationschirurgie, Universitätsklinikum HeidelbergPD Dr. Dr. Susanne RothIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- 00496221565150
- Fax:
- 00496221565969
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Chirurgische Klinik, Abteilung für Allgemein-, Viszeral-und Transplantationschirurgie, Universitätsklinikum HeidelbergPD Dr. Dr. Susanne RothIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- 00496221565150
- Fax:
- 00496221565969
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- DFG53175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-01-06
- Ethics committee number:
- S-016/2020
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-02-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- The biosamples collected in the study are used for the analysis of circulating/disseminated tumor cells. Further analysis of the samples will not be possible due to the limited material.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry