FIBROPANC-1: Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Sponsor
Erasmus Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05641233
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
33
2
1
26.9
16.5
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic radiotherapy
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

Radiation: Stereotactic radiotherapy
Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.

Outcome Measures

Primary Outcome Measures

  1. Safety - CTCAE grade 3-4-5 complications related to the intervention [Up to 30 days after surgery]

  2. 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 Outcome Measures

  1. 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)

  2. Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon [Assesment during surgery]

    Texture is scaled as soft/intermediate/hard

  3. Macroscopic tissue assessment, determined by the pathologist [Histopathological assesment after surgery]

    Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue

  4. Surgery related postoperative complications defined according to the Clavien-Dindo classification [Up to 30 days after surgery]

  5. Overall complications [Up to 30 days after surgery]

  6. Readmission rate [Postoperative period]

  7. Length of hospital stay [Up to 30 days after surgery]

    Days

  8. 30-day mortality and in-hospital mortality [Up to 30 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amsterdam UMC Amsterdam North-Holland Netherlands
2 Erasmus Medical Center Rotterdam South-Holland Netherlands

Sponsors and Collaborators

  • Erasmus Medical Center
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Casper H.J. van Eijck, prof. dr. Casper H.J. van Eijck, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT05641233
Other Study ID Numbers:
  • NL72913.018.20
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Casper H.J. van Eijck, prof. dr. Casper H.J. van Eijck, Erasmus Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2022