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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Digestive System Fistula
Pathological Conditions, Anatomical
Digestive System Diseases
Pancreatic Diseases
Octreotide
Pancrelipase
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 24, 2014