Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Pancreatic Fistula Clinical Trial

— FIBROPANC-1  

Official title:

Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641233
• Other study ID #: NL72913.018.20
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: November 2022
• Source: Erasmus Medical Center
• Contact: Leonoor Wismans
• Phone: 010-703 38 54
• Email: l.wismans[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Cholangiocarcinoma
• Fibrosis
• Fistula
• GIST
• Neuroendocrine Carcinoma of Pancreas
• Pancreas Neoplasm
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	North-Holland
Netherlands	Erasmus Medical Center	Rotterdam	South-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - CTCAE grade 3-4-5 complications related to the intervention		Up to 30 days after surgery
Primary	Hardness of pancreas texture, determined by Durometer measurement	Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO	Histopathological assesment of tissue after surgery
Secondary	Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C	Defined by the ISGPS guideline (2016)	Up to 30 days after operation
Secondary	Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon	Texture is scaled as soft/intermediate/hard	Assesment during surgery
Secondary	Macroscopic tissue assessment, determined by the pathologist	Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue	Histopathological assesment after surgery
Secondary	Surgery related postoperative complications defined according to the Clavien-Dindo classification		Up to 30 days after surgery
Secondary	Overall complications		Up to 30 days after surgery
Secondary	Readmission rate		Postoperative period
Secondary	Length of hospital stay	Days	Up to 30 days after surgery
Secondary	30-day mortality and in-hospital mortality		Up to 30 days after surgery