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	https://doi.org/10.1186/ISRCTN58328599
Secondary identifying numbers	PI08621

Submission date: 20/01/2013
Registration date: 07/02/2013
Last edited: 21/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Joan Figueras Felip
Scientific

Hepato-biliary and pancreatic surgery
Department of Surgery
Dr Josep Trueta Hospital
Girona
17007
Spain

Phone	+34 (0)972 940 256
Email	info@jfigueras.net

Study information

Study design	Randomised prospective controlled parallel-group multicentre trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Pancreatogastrostomy vs. pancreatojejunostomy for reconstruction of the pancreatic remnant after pancreatoduodenotomy: a prospective, randomised, controlled, metacentre study
Study acronym	PGvsPJ
Study objectives	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(s)	Ethics committee of the Doctor Josep Trueta University Hospital in Girona, 01/02/2008
Health condition(s) or problem(s) studied	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
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 study start date	22/02/2008
Completion date	28/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	130 patients
Key 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
Key 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
Date of first enrolment	22/02/2008
Date of final enrolment	28/02/2013

Locations

Countries of recruitment

Spain

Study participating centre

Dr Josep Trueta Hospital

Girona
17007
Spain

Sponsor information

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Hospital/treatment centre

S.G. de Evaluación y Fomento de la Investigación
Fondo de Investigación Sanitaria
C/Sinesio Delgado 6
Madrid
28029
Spain

Email	nchico@idibgi.org
"ROR"	https://ror.org/00ca2c886

Funders

Funder type

Hospital/treatment centre

Instituto de Salud Carlos III (Spain) FIS (Registration number PI08621)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2013		Yes	No

Editorial Notes

21/10/2016: Plain English summary added.