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ISRCTN
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ISRCTN58328599
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DOI
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10.1186/ISRCTN58328599
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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To determine whether reconstruction of pancreatic remnant with the stomach after pancreatoduodenotomy can be safe and acceptably decreases the rate of pancreatic fistulas compared with reconstruction with the small bowel
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Scientific title
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Pancreatogastrostomy vs. pancreatojejunostomy for reconstruction of the pancreatic remnant after pancreatoduodenotomy: a prospective, randomised, controlled, metacentre study
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Acronym
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PGvsPJ
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Serial number at source
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PI08621
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Study hypothesis
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Pancreato-gastric anastomosis of the pancreas with the stomach after pancreatoduodenotomy presents less incidence of pancreatic fistula than the standard reconstruction with pancreato-jejunostomy.
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Lay summary
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Lay summary under review 1
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Ethics approval
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Ethics approval received from the local medical Ethical Committee, CEIC, 9a planta A. Hospital University of Girona Dr. Josep Trueta. Avda. de França s/n. 17007 Girona . Spain, February 1, 2008
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Study design
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Randomised prospective controlled parallel group multicentre trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Pancreatectomy
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Participants - inclusion criteria
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1. Consecutive patients who will undergo pancreatodudodenectomy (DPC) at Hospital Clinico de Valencia and Hospital “Dr Josep Trueta” in Girona Spain. Coordinated by “Dr. Josep Trueta” Hospital of Girona.
2. Patients aged 18 to 80 years, either sex
3. Pancreatectomy is indicated because of a benign or malignant tumour of the pancreas, chronic pancreatitis or malignant neoplasm of other organs infiltrating the pancreas, provided the parenchyma of the pancreas is suitable for anastomosis.
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Participants - exclusion criteria
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1. Patients who at the time of surgery are found not resectable
2. Associated resection of other organs, excluding the superior mesenteric vein
3. American Society of Anaesthesiologists (ASA) anesthetic risk 4 as the American Association of Anesthesiologists
4. Pancreatoduodenectomy (PD) for calcifying chronic pancreatitis
5. PD palliative leaving macroscopic tumor
6. Preoperative obstructive jaundice with bilirubin> 300μmol or 15 mg / L
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Anticipated start date
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22/02/2008
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Anticipated end date
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28/02/2013
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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130 patients
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Interventions
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Group PG Pancreatogastric anastomois of the pancreatic remnant to the stomach
Group PJ Pancreatojejunostomy anastomois of the pancreatic remnant to the jejunum
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Primary outcome measure(s)
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Rate of pancreatic fistula will be evaluated at the time of hospital discharge and at 3 months post-operatively. The severity of the PF will be evaluated with the ISGPH score.
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Secondary outcome measure(s)
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1. Mortality and morbidity
2. Complications graded according to Dindo-Clavien classification.
3. Reoperation rate
4. Readmissions and hospital stay
Evaluated at the time of hospital discharge and at 3 months post-operatively.
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Sources of funding
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Instituto de Salud Carlos III (Spain) FIS (Registration number PI08621)
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Trial website
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Publications
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Contact name
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Prof
Joan
Figueras Felip
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Address
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Hepato-biliary and pancreatic surgery
Department of Surgery
“Dr Josep Trueta” Hospital
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City/town
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Girona
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Zip/Postcode
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17007
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Country
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Spain
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Tel
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+34 972 940 256
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Fax
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+34 972 940 270
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Email
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info@jfigueras.net
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Sponsor
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Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
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Address
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S.G. de Evaluación y Fomento de la Investigación
Fondo de Investigación Sanitaria
C/Sinesio Delgado 6
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City/town
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Madrid
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Zip/Postcode
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28029
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Country
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Spain
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Email
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nchico@idibgi.org
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Date applied
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20/01/2013
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Last edited
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07/02/2013
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Date ISRCTN assigned
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07/02/2013
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