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

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ClinicalTrials.gov Identifier: NCT01301222
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Prakash K, PVS Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Drug: Inj. Octreotide Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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



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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

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

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 Posted: February 23, 2011    Key Record Dates
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