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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

Pancreatogastrostomy vs. pancreatojejunostomy for reconstruction of the pancreatic remnant after pancreatoduodenotomy: a prospective, randomised, controlled, metacentre study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58328599
Enrollment
130
Registered
2013-02-07
Start date
2008-02-22
Completion date
Unknown
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatectomy Surgery

Interventions

Group PG: Pancreatogastric anastomois of the pancreatic remnant to the stomach Group PJ: Pancreatojejunostomy anastomois of the pancreatic remnant to the jejunum

Sponsors

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026