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NCT Number: NCT01301222

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

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.

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Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PVS Memorial Hospital

Kochi, Kerala, 682017, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inj. Octreotide

Drug

100 mcg subcutaneously for 5 days

Other names: Inj Octride

Primary outcomes

  1. Pancreatic fistula

    Time frame: 30 days

    All grades of postoperative pancreatic fistula as per ISGPF definition

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

PVS Memorial Hospital

Other

Registry information

Official study title

Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas

Acronym: PD

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Feb 23, 2011
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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