Pancreatic Fistula
Conditions
Keywords
octreotide, pancreatic fistula, soft pancreas, pancreatoduodenectomy
Brief summary
This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas. Previously reported trials have included all types of pancreatic resections and have include all types of pancreas and have shown no clearcut benefit of octreotide after pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for fistula following PD. This study's focus is on this select group of patients and aims to assess the role of octreotide in patients with soft pancreas.
Detailed description
Study design: Prospective open labeled randomized trial. AIM: Study aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.
Interventions
DRUGInj. Octreotide
100 mcg subcutaneously for 5 days
Sponsors
PVS Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
elective surgery patients undergoing pancreatoduodenectomy * soft pancreas, no dilated duct
Exclusion criteria
* age \> 75 years old * documented chronic pancreatitis * previous pancreatic surgery * previous gastric surgery vagotomy * documented pancreatic duct dilatation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic fistula | 30 days | All grades of postoperative pancreatic fistula as per ISGPF definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications | 30 days | All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored |
Countries
India
Outcome results
None listed