NCT01301222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

4 years

First QC Date

February 22, 2011

Last Update Submit

February 21, 2015

Conditions

Pancreatic Fistula

Keywords

octreotidepancreatic fistulasoft pancreaspancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Pancreatic fistula

    All grades of postoperative pancreatic fistula as per ISGPF definition

    30 days

Secondary Outcomes (1)

  • complications

    30 days

Study Arms (1)

octreotide

EXPERIMENTAL

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

Drug: Inj. Octreotide

Interventions

Inj. OctreotideDRUG

100 mcg subcutaneously for 5 days

Also known as: Inj Octride
octreotide

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • soft pancreas, no dilated duct

You may not qualify if:

  • age \> 75 years old
  • documented chronic pancreatitis
  • previous pancreatic surgery
  • previous gastric surgery vagotomy
  • documented pancreatic duct dilatation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PVS Memorial Hospital

Kochi, Kerala, 682017, India

Location

Related Publications (4)

  • 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.

    PMID: 17903728BACKGROUND

  • 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.

    PMID: 10973392BACKGROUND

  • 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.

    PMID: 15006886BACKGROUND

  • 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.

    PMID: 26302879DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Prakash Kurumboor, MS,MCh

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief GI Surgeon

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

IN(1)