Back to resultsPreoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy (FIBROPANC-1)
Primary Purpose
Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm
Status
Recruiting
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Stereotactic radiotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Neuroendocrine Carcinoma of Pancreas focused on measuring Post operative pancreatic fistula, Stereotactic radiotherapy, Pancreatic fibrosis, Pancreatoduodenectomy
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
Sites / Locations
- Amsterdam UMCRecruiting
- Erasmus Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Outcomes
Primary Outcome Measures
Safety - CTCAE grade 3-4-5 complications related to the intervention
Hardness of pancreas texture, determined by Durometer measurement
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
Secondary Outcome Measures
Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C
Defined by the ISGPS guideline (2016)
Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon
Texture is scaled as soft/intermediate/hard
Macroscopic tissue assessment, determined by the pathologist
Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue
Surgery related postoperative complications defined according to the Clavien-Dindo classification
Overall complications
Readmission rate
Length of hospital stay
Days
30-day mortality and in-hospital mortality
Full Information
NCT ID
NCT05641233
First Posted
November 17, 2022
Last Updated
November 29, 2022
Sponsor
Erasmus Medical Center
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05641233
Brief Title
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Acronym
FIBROPANC-1
Official Title
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Intervention Description
Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.
Primary Outcome Measure Information:
Title
Safety - CTCAE grade 3-4-5 complications related to the intervention
Time Frame
Up to 30 days after surgery
Title
Hardness of pancreas texture, determined by Durometer measurement
Description
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
Time Frame
Histopathological assesment of tissue after surgery
Secondary Outcome Measure Information:
Title
Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C
Description
Defined by the ISGPS guideline (2016)
Time Frame
Up to 30 days after operation
Title
Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon
Description
Texture is scaled as soft/intermediate/hard
Time Frame
Assesment during surgery
Title
Macroscopic tissue assessment, determined by the pathologist
Description
Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue
Time Frame
Histopathological assesment after surgery
Title
Surgery related postoperative complications defined according to the Clavien-Dindo classification
Time Frame
Up to 30 days after surgery
Title
Overall complications
Time Frame
Up to 30 days after surgery
Title
Readmission rate
Time Frame
Postoperative period
Title
Length of hospital stay
Description
Days
Time Frame
Up to 30 days after surgery
Title
30-day mortality and in-hospital mortality
Time Frame
Up to 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonoor Wismans
Phone
010-703 38 54
Email
l.wismans@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa Hendriks
Email
t.e.hendriks@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
North-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tessa Hendriks
Email
t.e.hendriks@amsterdamumc.nl
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
South-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonoor Wismans
Email
l.wismans@erasmusmc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
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