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Closure of the Pancreatic Remnant after Distal Pnacreatectomy A prospective randomized controlled trial


- candidate number25271
- NTR NumberNTR6048
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2016
- Secondary IDsMEC-2009-347 NL29396.078.09
- Public TitleClosure of the Pancreatic Remnant after Distal Pnacreatectomy A prospective randomized controlled trial
- Scientific TitleClosure of the Pancreatic Remnant after Distal Pnacreatectomy A prospective randomized controlled trial
- ACRONYMCPR
- hypothesisDetermine which technique for sealing of the pancreatic remnant after distal pancreatectomy optimally closes the pancreatic remnant, leading to the lowest incidence of pancreatic fistula.
- Healt Condition(s) or Problem(s) studiedChronic pancreatitis, Pancreatitis
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-mrt-2018
- Target number of participants250
- Interventionsplacement of a collagen patch on the sutured or stapled pancreatic remnant, with a sutured/stapled closed pancreatic remnant as control.
- Primary outcomedevelopment of pancreatic fistula
- Secondary outcomemortality
morbidity
costs
- Timepointsscreening
day of surgery
day 10 post-operative
day 30 post-operative
6 months post-operative
12 months post-operative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. C.H.J. van Eijck
- CONTACT for SCIENTIFIC QUERIESProf. dr. C.H.J. van Eijck
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Pancreas research fonds
- Publications
- Brief summaryInappropriate 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.
- Main changes (audit trail)
- RECORD8-sep-2016 - 10-nov-2016


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