Clinical Trial: Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas

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 Summary: 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.
Sponsor: PVS Memorial Hospital

Current Primary Outcome: Pancreatic fistula [ Time Frame: 30 days ]

All grades of postoperative pancreatic fistula as per ISGPF definition


Original Primary Outcome: Same as current

Current Secondary Outcome: complications [ Time Frame: 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


Original Secondary Outcome: complications [ Time Frame: 30 days ]

All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intraabdminal collections, respiratory complications, DGE etc are monitored


Information By: PVS Memorial Hospital

Dates:
Date Received: February 22, 2011
Date Started: September 2010
Date Completion:
Last Updated: February 21, 2015
Last Verified: February 2015