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.
ID
Bron
Verkorte titel
Aandoening
chronic pancreatitis, cystic pancreatic lesions, malignant pancreatic lesions and neuroendocrine tumors located in the body or tail of the pancreas.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
development of pancreatic fistula
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
screening
day of surgery
day 10 post-operative
day 30 post-operative
6 months post-operative
12 months post-operative
Onderzoeksproduct en/of interventie
placement of a collagen patch on the sutured or stapled pancreatic remnant, with a sutured/stapled closed pancreatic remnant as control.
Publiek
C.H.J.
van Eijck
Wetenschappelijk
C.H.J.
van Eijck
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Current immunosuppresive therapy
- Chemotherapy within 2 weeks before operation
- Curative resection not feasable
- Severe psychiatrric or neurologic disease
- Drug and/or alcohol abuse
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5876 |
| NTR-old | NTR6048 |
| Ander register | NL29396.078.09 : MEC-2009-347 |