Plain English Summary
Background and study aims
Pancreaticoduodenectomy (PD) is surgery to remove part of the pancreas and part of the stomach. It is the best treatment for patients with pancreatic cancer. However, PD can lead to leakage (called pancreatic fistula) with a significant risk of illness and death. It is not known which reconstruction method is to best at reducing the risk of fistula. Pancreaticojejunostomy (PJ) involves connecting the remnant of the pancreas to the middle portion of the small intestine, and is the most commonly used reconstructive method after PD. Pancreaticogastrostomy (PG) involves connecting the remnant of the pancreas to the stomach, and may have a lower risk of fistula. The aim of this study is to compare the rate of fistula and other complications between both methods.
Who can participate?
Patients aged 18 to 80 undergoing PD for pancreatic tumours, chronic pancreatitis (long-term inflammation of the pancreas), or cancer that has spread to the pancreas
What does the study involve?
Participants are randomly allocated to one of two groups. One group undergoes PG surgery while the other group undergoes PJ surgery. Rate of pancreatic fistula, complications, further surgery, illness and death are measured in both groups at the time of hospital discharge and 3 months later.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but there may be a lower rate of pancreatic fistula with the PG surgery, which could benefit future patients. Previous studies suggest that PG is at least as safe as PJ.
Where is the study run from?
Hospital Clinico de Valencia and Hospital “Dr Josep Trueta” in Girona (Spain)
When is the study starting and how long is it expected to run for?
February 2008 to February 2013
Who is funding the study?
Instituto de Salud Carlos III (Spain)
Who is the main contact?
Prof. Joan Figueras Felip
info@jfigueras.net
Trial website
Contact information
Type
Scientific
Primary contact
Prof Joan Figueras Felip
ORCID ID
Contact details
Hepato-biliary and pancreatic surgery
Department of Surgery
Dr Josep Trueta Hospital
Girona
17007
Spain
+34 (0)972 940 256
info@jfigueras.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI08621
Study information
Scientific title
Pancreatogastrostomy vs. pancreatojejunostomy for reconstruction of the pancreatic remnant after pancreatoduodenotomy: a prospective, randomised, controlled, metacentre study
Acronym
PGvsPJ
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.
Ethics approval
Ethics committee of the Doctor Josep Trueta University Hospital in Girona, 01/02/2008
Study design
Randomised prospective controlled parallel-group multicentre trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Pancreatectomy
Intervention
Group PG: Pancreatogastric anastomois of the pancreatic remnant to the stomach
Group PJ: Pancreatojejunostomy anastomois of the pancreatic remnant to the jejunum
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Rate of pancreatic fistula, 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 measures
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.
Overall trial start date
22/02/2008
Overall trial end date
28/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130 patients
Participant 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
Recruitment start date
22/02/2008
Recruitment end date
28/02/2013
Locations
Countries of recruitment
Spain
Trial participating centre
Dr Josep Trueta Hospital
Girona
17007
Spain
Sponsor information
Organisation
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Sponsor details
S.G. de Evaluación y Fomento de la Investigación
Fondo de Investigación Sanitaria
C/Sinesio Delgado 6
Madrid
28029
Spain
-
nchico@idibgi.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Instituto de Salud Carlos III (Spain) FIS (Registration number PI08621)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24264781
Publication citations
-
Results
Figueras J, Sabater L, Planellas P, Muñoz-Forner E, Lopez-Ben S, Falgueras L, Sala-Palau C, Albiol M, Ortega-Serrano J, Castro-Gutierrez E, Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy on the rate and severity of pancreatic fistula after pancreaticoduodenectomy., Br J Surg, 2013, 100, 12, 1597-1605, doi: 10.1002/bjs.9252.