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

Primary Purpose

Pancreatic Fistula

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Inj. Octreotide
Sponsored by
PVS Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Fistula focused on measuring octreotide, pancreatic fistula, soft pancreas, pancreatoduodenectomy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PVS Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

octreotide

Arm Description

octreotide arm 100mcg for 5 days. control has no octreotide

Outcomes

Primary Outcome Measures

Pancreatic fistula
All grades of postoperative pancreatic fistula as per ISGPF definition

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2011
Last Updated
February 21, 2015
Sponsor
PVS Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01301222
Brief Title
Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas
Acronym
PD
Official Title
Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
PVS Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula
Keywords
octreotide, pancreatic fistula, soft pancreas, pancreatoduodenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
octreotide
Arm Type
Experimental
Arm Description
octreotide arm 100mcg for 5 days. control has no octreotide
Intervention Type
Drug
Intervention Name(s)
Inj. Octreotide
Other Intervention Name(s)
Inj Octride
Intervention Description
100 mcg subcutaneously for 5 days
Primary Outcome Measure Information:
Title
Pancreatic fistula
Description
All grades of postoperative pancreatic fistula as per ISGPF definition
Time Frame
30 days
Secondary Outcome Measure Information:
Title
complications
Description
All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prakash Kurumboor, MS,MCh
Organizational Affiliation
GI Surgeon,PVS Memorial Hospital,Kochi, Kerala,India
Official's Role
Principal Investigator
Facility Information:
Facility Name
PVS Memorial Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682017
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
17903728
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. doi: 10.1016/j.jamcollsurg.2007.05.011. Epub 2007 Aug 23.
Results Reference
background
PubMed Identifier
10973392
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. doi: 10.1097/00000658-200009000-00014.
Results Reference
background
PubMed Identifier
15006886
Citation
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. doi: 10.1001/archsurg.139.3.288.
Results Reference
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PubMed Identifier
26302879
Citation
Kurumboor P, Palaniswami KN, Pramil K, George D, Ponnambathayil S, Varma D, Aikot S. Octreotide Does Not Prevent Pancreatic Fistula Following Pancreatoduodenectomy in Patients with Soft Pancreas and Non-dilated Duct: A Prospective Randomized Controlled Trial. J Gastrointest Surg. 2015 Nov;19(11):2038-44. doi: 10.1007/s11605-015-2925-x. Epub 2015 Aug 25.
Results Reference
derived

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

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