Distal Cholangiocarcinoma, Duodenum Carcinoma, GIST, Neuroendocrine Carcinoma of Pancreas, Pancreas Fibrosis, Pancreas Neoplasm, Pancreatic Fistula
Conditions
Keywords
Post operative pancreatic fistula, Stereotactic radiotherapy, Pancreatic fibrosis, Pancreatoduodenectomy
Brief summary
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (\>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.
Interventions
RADIATIONStereotactic radiotherapy
Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma. * Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site). * WHO-ECOG performance status 0,1 or 2. * Ability to undergo stereotactic radiotherapy and surgery. * Age ≥ 18 years. * Good understanding of the oral and written patient information provided. * Written informed consent.
Exclusion criteria
* Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region. * Patients with (a history of) chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - CTCAE grade 3-4-5 complications related to the intervention | Up to 30 days after surgery | — |
| Hardness of pancreas texture, determined by Durometer measurement | Histopathological assesment of tissue after surgery | Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macroscopic tissue assessment, determined by the pathologist | Histopathological assesment after surgery | Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue |
| Surgery related postoperative complications defined according to the Clavien-Dindo classification | Up to 30 days after surgery | — |
| Overall complications | Up to 30 days after surgery | — |
| Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C | Up to 30 days after operation | Defined by the ISGPS guideline (2016) |
| Length of hospital stay | Up to 30 days after surgery | Days |
| 30-day mortality and in-hospital mortality | Up to 30 days after surgery | — |
| Readmission rate | Postoperative period | — |
| Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon | Assesment during surgery | Texture is scaled as soft/intermediate/hard |
Countries
Netherlands
Contacts
Primary ContactLeonoor Wismans
Backup ContactTessa Hendriks
Outcome results
None listed