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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301222
First Posted: February 23, 2011
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Prakash K, PVS Memorial Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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 Dr Prakash K, PVS Memorial Hospital:

Primary Outcome Measures:
  • Pancreatic fistula [ Time Frame: 30 days ]
    All grades of postoperative pancreatic fistula as per ISGPF definition


Secondary Outcome Measures:
  • complications [ Time Frame: 30 days ]
    All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored


Enrollment: 110
Study Start Date: September 2010
Study Completion Date: February 2015
Primary Completion Date: September 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301222


Locations
India
PVS Memorial Hospital
Kochi, Kerala, India, 682017
Sponsors and Collaborators
PVS Memorial Hospital
Investigators
Principal Investigator: Prakash Kurumboor, MS,MCh GI Surgeon,PVS Memorial Hospital,Kochi, Kerala,India
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Prakash K, Chief GI Surgeon, PVS Memorial Hospital
ClinicalTrials.gov Identifier: NCT01301222     History of Changes
Other Study ID Numbers: PVSMHEC
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Dr Prakash K, 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
Pancrelipase
Pancreatin
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents