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

Erasmus Medical Center33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Neuroendocrine Carcinoma of Pancreas Duodenum Carcinoma Pancreas Neoplasm Distal Cholangiocarcinoma GIST

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Safety - CTCAE grade 3-4-5 complications related to the intervention

Time frame: Up to 30 days after surgery

Hardness of pancreas texture, determined by Durometer measurement

Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO

Time frame: Histopathological assesment of tissue after surgery

Secondary Outcomes

Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C

Defined by the ISGPS guideline (2016)

Time frame: Up to 30 days after operation

Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon

Texture is scaled as soft/intermediate/hard

Time frame: Assesment during surgery

Macroscopic tissue assessment, determined by the pathologist

Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue

Time frame: Histopathological assesment after surgery

Surgery related postoperative complications defined according to the Clavien-Dindo classification

Time frame: Up to 30 days after surgery

Overall complications

Time frame: Up to 30 days after surgery

Readmission rate

Time frame: Postoperative period

Length of hospital stay

Days

Time frame: Up to 30 days after surgery

30-day mortality and in-hospital mortality

Time frame: Up to 30 days after surgery

Central Contacts

Leonoor Wismans

CONTACT

010-703 38 54 l.wismans@erasmusmc.nl

Tessa Hendriks

CONTACT

t.e.hendriks@amsterdamumc.nl

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts