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

PVS Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Pancreatic Fistula

Treatments: Drug: Inj. Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT01301222

PVSMHEC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

octreotide

Experimental group

Description:

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

Treatment:

Drug: Inj. Octreotide