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The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with peritoneal carcinomatosis | Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPAC | Procedure |
The chemotherapeutics will be admitted to the abdomen by a nebulizer at a pressure of 200 psi and 12 mmHG with 0.5 mL/sec. Afterwards the chemotherapeutics can react for 30min before the abdominal gas will be drained to the clinics filtering system. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (years) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments | 25 weeks | |
| Overall Response Rate (CT RESIST criteria) | Complete response | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffer from peritoneal carcinomatosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ines Gockel, Prof. Dr. | Contact | +49 341 97 17200 | ines.gockel@medizin.uni-leipzig.de | |
| Boris Jansen-Winkeln, Dr. | Contact | +49 341 97 17200 | boris.jansen-winkeln@medizin.uni-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Ines Gockel, Prof. Dr. | Universitätsklinikum Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Leipzig - AöR | Recruiting | Leipzig | Saxony | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36513815 | Derived | Jansen-Winkeln B, Eberth J, Moulla Y, Mehdorn M, Niebisch S, Schierle K, Blaker H, Lordick F, Gockel I, Thieme R. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal surface malignancies (PSM): a prospective single-center registry study. J Cancer Res Clin Oncol. 2023 Mar;149(3):1331-1341. doi: 10.1007/s00432-022-04517-w. Epub 2022 Dec 13. | |
| 31469058 |
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| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| Quality of lfe questionnaire (EORTC QLQ-C15-PAL) | Groenvold M et al. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. European Journal of Cancer 2006; 42(1): 55-64 | 5 years |
| Derived |
| Gockel I, Jansen-Winkeln B, Haase L, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer. Tumori. 2020 Feb;106(1):70-78. doi: 10.1177/0300891619868013. Epub 2019 Aug 30. |
| 30607301 | Derived | Gockel I, Jansen-Winkeln B, Haase L, Rhode P, Mehdorn M, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Cancer Patients with Peritoneal Metastasis (PM): Results of a Single-Center Experience and Register Study. J Gastric Cancer. 2018 Dec;18(4):379-391. doi: 10.5230/jgc.2018.18.e37. Epub 2018 Dec 14. |
| D004066 |
| Digestive System Diseases |
| D010532 | Peritoneal Diseases |