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
- Conditions
- PancreatectomySurgery
- Registration Number
- ISRCTN58328599
- Lead Sponsor
- Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
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
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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Mortality and morbidity<br>2. Complications graded according to Dindo-Clavien classification<br>3. Reoperation rate<br>4. Readmissions and hospital stay<br>Evaluated at the time of hospital discharge and at 3 months post-operatively.