ISRCTN - ISRCTN58328599: 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

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 type

Hospital/treatment centre

Website

Funders

Funder type