No registrations found.
ID
Source
Brief title
Health condition
chronic pancreatitis, cystic pancreatic lesions, malignant pancreatic lesions and neuroendocrine tumors located in the body or tail of the pancreas.
Sponsors and support
Intervention
Outcome measures
Primary outcome
development of pancreatic fistula
Secondary outcome
mortality
morbidity
costs
Background summary
Inappropriate closure of the pancreatic remnant after distal pancreatectomy remains a common source
of morbidity. Pancreatic fistula and leakage are the most common and clinically relevant complications,
and they are thought to depend on surgical technique and skill. A variety of procedures have been
recommended to reduce the frequency of pancreatic fistula. Results of previously described techniques
after pancreatico-duodenectomy suggest that outcome with regard to pancreatic fistula can be
improved using a fibrinogen/thrombin coated collagen patch (TachoSil) in carrying out pancreatico-
jejunostomy. The CPR trial will compare a standard method of hand- or stapled closure of the pancreatic
remnant with or without the use of a collagen patch. If the collagen patch is effective in reducing
pancreatic fistula and overall morbidity it has potential to improve quality of life and reduce medical
costs.
Study objective
Determine which technique for sealing of the pancreatic remnant after distal pancreatectomy optimally closes the pancreatic remnant, leading to the lowest incidence of pancreatic fistula.
Study design
screening
day of surgery
day 10 post-operative
day 30 post-operative
6 months post-operative
12 months post-operative
Intervention
placement of a collagen patch on the sutured or stapled pancreatic remnant, with a sutured/stapled closed pancreatic remnant as control.
C.H.J.
van Eijck
C.H.J.
van Eijck
Inclusion criteria
- Age above 18 years
- Expected survival time more than 12 months
- WHO Karnofsky performance status >50% / ASA I-II
- Patients with chronic pancreatitis, cystic pancreatic lesions, malignant pancreatic lesions and neuroendocrine tumors located in the body or tail of the pancreas.
- patients who are planned to undergo distal pancreatectomy as part of an extensive resection for other malignancies (i.e. sarcoma, GIST, gastric carcinoma).
- written informed consent
Exclusion criteria
- Current immunosuppresive therapy
- Chemotherapy within 2 weeks before operation
- Curative resection not feasable
- Severe psychiatrric or neurologic disease
- Drug and/or alcohol abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5876 |
| NTR-old | NTR6048 |
| Other | NL29396.078.09 : MEC-2009-347 |