To investigate the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk of developing postoperative pancreatic fistula (>25%).
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main aim of this study are both to determine the safety (patients with
CTCAE grade 3-4-5 complications) and efficacy (significant change in the
within-patient durometer measurements of radiated and non-radiated pancreatic
texture) of preoperative radiotherapy. If both criteria for safety and efficacy
are met, the endpoint POPF Grade B and C is assessed in 13 more patients,
totalling 33 patients.
Secondary outcome
The main secondary outcome is the postoperative occurrence of postoperative
fistula grade B or C.
Other outcomes:
Overall complications
Duration of admission in days
Readmission rate
Background summary
Postoperative pancreatic fistula (POPF) is a potential life-threatening
complication after pancreatoduodenectomy. POPF is caused by an anastomotic
dehiscence of the pancreato-jejunostomy or pancreato-gastrostomy created in the
reconstruction phase of a pancreatoduodenectomy (i.e. Whipple) procedure. It
occurs in approximately 15% of all patients undergoing pancreatoduodenectomy
and is the primary cause of complications after this procedure, associated with
increase in length of hospital stay, radiological or surgical interventions,
higher readmission rates, higher costs and even death in up to 25-30% of
patients with POPF. Soft pancreatic texture, small pancreatic duct diameter,
high BMI and male sex are well-known risk factors for the development of POPF.
However, if patients have a tumor of the peri-ampullary region with
additionally a narrow pancreatic duct diameter, the risk of developing a
pancreatic fistula is very high (> 25%). For this group, it is essential to
reduce the risk of developing a pancreatic fistula and the secondary risk of
death.
Study objective
To investigate the feasibility and safety of preoperative stereotactic
radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at
high risk of developing postoperative pancreatic fistula (>25%).
Study design
Prospective phase II single-arm feasibility study
Intervention
Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on
4cm pancreas at the intended (i.e. future) anastomotic site.
Study burden and risks
Endoscopic placement of a marker can cause nausea and abdominal cramps.
Complications are seen in less than 5% of cases and can include pancreatitis,
cholangitis, or bleeding.
(Sub) acute toxicity related to radiotherapy can consist of tiredness or
gastrointestinal complaints (nausea, vomiting or diarrhea, gastric ulcers).
Late effects of radiatiotherapy can consist of strictures or development of
secondary neoplasms. With this single radiotherapy dose, these risks are
considered negligible.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
- Contra-indications for MRI (only for VUmc and UMCU), (e.g. presence of a
pacemaker or defibrillator, metal splinters).
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL72913.018.20 |