Pancreatic Cancer, Pancreatic Fistula
Conditions
Keywords
Pancreatic anastomosis, Whipple operation
Brief summary
There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected. Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior
Interventions
PROCEDUREtype of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
Sponsors
Lakeshore Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head 2. resectable tumour
Exclusion criteria
1. chronic pancreatitis/benign tumours- 2. tumours extending into the body of the pancreas 3. tumours with metastasis beyond regional lymph nodes 4. requirement for sub total pancreatectomy 5. prolonged hypotension - \< 80 mm of hg for more than 30 min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pancreatic fistula rate | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| mortality | 90 days |
| Hospital stay | 90 days |
| need for postoperative intervention | 90 days |
| major complication | 90 days |
Countries
India
Outcome results
None listed