Pancreatic Fistula Clinical Trial
— PDOfficial title:
Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas
| Verified date | February 2015 |
| Source | PVS Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 110 |
| Est. completion date | February 2015 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | PVS Memorial Hospital | Kochi | Kerala |
| Lead Sponsor | Collaborator |
|---|---|
| PVS Memorial Hospital |
India,
Suc B, Msika S, Piccinini M, Fourtanier G, Hay JM, Flamant Y, Fingerhut A, Fagniez PL, Chipponi J; French Associations for Surgical Research. Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial. Arch Surg. 2004 Mar;139(3):288-94; discussion 295. — View Citation
Vanounou T, Pratt WB, Callery MP, Vollmer CM Jr. Selective administration of prophylactic octreotide during pancreaticoduodenectomy: a clinical and cost-benefit analysis in low- and high-risk glands. J Am Coll Surg. 2007 Oct;205(4):546-57. Epub 2007 Aug 23. — View Citation
Yeo CJ, Cameron JL, Lillemoe KD, Sauter PK, Coleman J, Sohn TA, Campbell KA, Choti MA. Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial. Ann Surg. 2000 Sep;232(3):419-29. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pancreatic fistula | All grades of postoperative pancreatic fistula as per ISGPF definition | 30 days | No |
| Secondary | complications | All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored | 30 days | No |
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