Clinical trial NCT05641233: Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Official title: Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Carcinoma of Pancreas
Duodenum Carcinoma
Pancreas Neoplasm
Distal Cholangiocarcinoma
GIST
Pancreas Fibrosis
Pancreatic Fistula
Keywords: Post operative pancreatic fistula
Stereotactic radiotherapy
Pancreatic fibrosis
Pancreatoduodenectomy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2022-12-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety - CTCAE grade 3-4-5 complications related to the intervention
timeFrame: Up to 30 days after surgery
measure: Hardness of pancreas texture, determined by Durometer measurement
timeFrame: Histopathological assesment of tissue after surgery
Secondary outcomes:
measure: Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C
timeFrame: Up to 30 days after operation
measure: Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon
timeFrame: Assesment during surgery
measure: Macroscopic tissue assessment, determined by the pathologist
timeFrame: Histopathological assesment after surgery
measure: Surgery related postoperative complications defined according to the Clavien-Dindo classification
timeFrame: Up to 30 days after surgery
measure: Overall complications
timeFrame: Up to 30 days after surgery
measure: Readmission rate
timeFrame: Postoperative period
measure: Length of hospital stay
timeFrame: Up to 30 days after surgery
measure: 30-day mortality and in-hospital mortality
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: North-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South-Holland
Study officials:
References: