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

This study is currently recruiting participants.

Verified September 2012 by PVS Memorial Hospital

Sponsor:

Information provided by (Responsible Party):

Dr Prakash K, PVS Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01301222

First received: February 22, 2011

Last updated: September 16, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Pancreatic Fistula	Drug: Inj. Octreotide	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas

Resource links provided by NLM:

MedlinePlus related topics: Fistulas

Drug Information available for: Pancreatin Pancrelipase Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by PVS Memorial Hospital:

Primary Outcome Measures:

Pancreatic fistula [ Time Frame: 30 days ] [ Designated as safety issue: No ]
All grades of postoperative pancreatic fistula as per ISGPF definition

Secondary Outcome Measures:

complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored

Estimated Enrollment:	90
Study Start Date:	September 2010
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: octreotide octreotide arm 100mcg for 5 days. control has no octreotide	Drug: Inj. Octreotide 100 mcg subcutaneously for 5 days Other Name: Inj Octride

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

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301222

Locations

India
PVS Memorial Hospital	Recruiting
Kochi, Kerala, India, 682017
Contact: Prakash Kurumboor, MS, MCh 09447302588 drkprakash@vsnl.com

Sponsors and Collaborators

PVS Memorial Hospital

Investigators

Principal Investigator:

Prakash Kurumboor, MS,MCh

GI Surgeon,PVS Memorial Hospital,Kochi, Kerala,India

More Information

Publications:

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.

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.

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.

Responsible Party:	Dr Prakash K, Chief GI Surgeon, PVS Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01301222 History of Changes
Other Study ID Numbers:	PVSMHEC
Study First Received:	February 22, 2011
Last Updated:	September 16, 2012
Health Authority:	India: Institutional Review Board

Keywords provided by PVS Memorial Hospital:

octreotide
pancreatic fistula
soft pancreas
pancreatoduodenectomy

Additional relevant MeSH terms:

Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Octreotide

Pancrelipase
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013

To Top