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

Phase 4

Completed

• Conditions: Pancreatic Fistula
• Interventions: Drug: Inj. Octreotide

• Registration Number: NCT01301222
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2014-09
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-21
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
octreotide	Inj. Octreotide	octreotide arm 100mcg for 5 days. control has no octreotide

Primary Outcome Measures

Name	Time	Method
Pancreatic fistula	30 days	All grades of postoperative pancreatic fistula as per ISGPF definition

Secondary Outcome Measures

Name	Time	Method
complications	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

Trial Locations

Locations (1)

PVS Memorial Hospital; 🇮🇳 Kochi, Kerala, India