Clinical trial NCT01301222: Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas
Official title: Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Fistula
Keywords: octreotide
pancreatic fistula
soft pancreas
pancreatoduodenectomy
Lead sponsor: PVS Memorial Hospital
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 110
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pancreatic fistula
timeFrame: 30 days
Secondary outcomes:
measure: complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Kochi
country: India
facility: PVS Memorial Hospital
state: Kerala
Study officials:
affiliation: GI Surgeon,PVS Memorial Hospital,Kochi, Kerala,India
name: Prakash Kurumboor, MS,MCh
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jamcollsurg.2007.05.011. Epub 2007 Aug 23.
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. doi: 10.1097/00000658-200009000-00014.
citation: 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. doi: 10.1001/archsurg.139.3.288.
citation: Kurumboor P, Palaniswami KN, Pramil K, George D, Ponnambathayil S, Varma D, Aikot S. Octreotide Does Not Prevent Pancreatic Fistula Following Pancreatoduodenectomy in Patients with Soft Pancreas and Non-dilated Duct: A Prospective Randomized Controlled Trial. J Gastrointest Surg. 2015 Nov;19(11):2038-44. doi: 10.1007/s11605-015-2925-x. Epub 2015 Aug 25.