Condition category
Surgery
Date applied
20/01/2013
Date assigned
07/02/2013
Last edited
05/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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
+34 972 940 256
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 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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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 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

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

Hepato-biliary and pancreatic surgery
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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24264781

Publication citations

  1. 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.

Additional files

Editorial Notes