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

Pancreatic Fistula Clinical Trial

— PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301222
• Other study ID #: PVSMHEC
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2011
• Last updated: February 21, 2015
• Start date: September 2010
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: PVS Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Drug:
• Inj. Octreotide
100 mcg subcutaneously for 5 days

Locations

Country	Name	City	State
India	PVS Memorial Hospital	Kochi	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
PVS Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (3)

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

Outcome

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