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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
ISRCTN ISRCTN58328599
DOI 10.1186/ISRCTN58328599
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title Pancreatogastrostomy vs. pancreatojejunostomy for reconstruction of the pancreatic remnant after pancreatoduodenotomy: a prospective, randomised, controlled, metacentre study
Acronym PGvsPJ
Serial number at source PI08621
Study hypothesis Pancreato-gastric anastomosis of the pancreas with the stomach after pancreatoduodenotomy presents less incidence of pancreatic fistula than the standard reconstruction with pancreato-jejunostomy.
Lay summary Lay summary under review 1
Ethics approval 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
Study design Randomised prospective controlled parallel group multicentre trial
Countries of recruitment Spain
Disease/condition/study domain Pancreatectomy
Participants - inclusion criteria 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.
Participants - exclusion criteria 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
Anticipated start date 22/02/2008
Anticipated end date 28/02/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 130 patients
Interventions Group PG Pancreatogastric anastomois of the pancreatic remnant to the stomach
Group PJ Pancreatojejunostomy anastomois of the pancreatic remnant to the jejunum
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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.
Sources of funding Instituto de Salud Carlos III (Spain) FIS (Registration number PI08621)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24264781
Contact name Prof  Joan  Figueras Felip
  Address Hepato-biliary and pancreatic surgery
Department of Surgery
“Dr Josep Trueta” Hospital
  City/town Girona
  Zip/Postcode 17007
  Country Spain
  Tel +34 972 940 256
  Fax +34 972 940 270
  Email info@jfigueras.net
Sponsor Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
  Address S.G. de Evaluación y Fomento de la Investigación
Fondo de Investigación Sanitaria
C/Sinesio Delgado 6
  City/town Madrid
  Zip/Postcode 28029
  Country Spain
  Email nchico@idibgi.org
Date applied 20/01/2013
Last edited 25/11/2013
Date ISRCTN assigned 07/02/2013
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