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Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis

Information source: Ospedale San Raffaele
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postpancreatectomy Hyperglycemia

Intervention: Pancreaticoduodenectomy with pancreatic anastomosis (Procedure); Total pancreatectomy with islet autotransplantation (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ospedale San Raffaele

Official(s) and/or principal investigator(s):
Lorenzo Piemonti, MD, Principal Investigator, Affiliation: Fondazione Centro San Raffaele del Monte Tabor
Gianpaolo Balzano, MD, Study Director, Affiliation: Fondazione Centro San Raffaele del Monte Tabor

Overall contact:
Lorenzo Piemonti, MD, Phone: 390226432706, Email: piemonti.lorenzo@hsr.it

Summary

The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas and pancreatic duct diameter <3 mm), total pancreatectomy with islet autotransplantation (IAT) is associated with a lower morbidity (in terms of surgical or medical complications) and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.

Clinical Details

Official title: Total Pancreatectomy With Islet Autotransplantation as a Superior Alternative to Pancreatoduodenectomy in Patients at Very High-risk of Complications of the Pancreatic Anastomosis: a Single-center Prospective Randomised Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: incidence of complications after pancreatic surgery

Secondary outcome:

Incidence of each individual postoperative complication

Incidence of endocrine and exocrine pancreatic insufficiency

Detailed description: Complications of the pancreatic anastomosis still represents a significant risk for death after the resection of the pancreatic head. In an effort to decrease morbidity and mortality, the referral of patients who need a pancreaticoduodenectomy to institutions (and surgeons) performing a high volume of this surgical procedure has been championed. Nonetheless, the role of prophylactic medications and the best surgical technique(s) for the removal of the pancreatic head are still debated. However, very few prospective randomized clinical trials have been conducted to compare different surgical techniques. Our study will address for the first time the role for preemptive total pancreatectomy and IAT in selected patients undergoing pancreaticoduodenectomy that are considered high risk for pancreaticojejunostomy disruption (eg, small pancreatic duct, soft pancreas). The information expected is the identification of total pancreatectomy and the IAT as the standard treatment in a subgroup of patient with pathologies of the pancreatic head at high risk for leakage of pancreatic anastomosis. Ultimately this project will lead to reserve more innovative cell therapy for patients with the highest risk of anastomosis failure reducing pancreatojejunal reconstruction related morbidity and mortality

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients >18 years of age

- Ability to provide written informed consent

- Mentally stable and able to comply with the procedures of the study protocol

- Fasting glycaemia <126 mg/dl without glucose-lowering medications.

Exclusion Criteria:

- Any medical condition that, in the opinion of the investigator, will interfere with

the safe completion of the trial

- Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal

lesion is demonstrated by endoscopic US

- Presence of multifocal or residual disease at the pancreatic margin.

Locations and Contacts

Lorenzo Piemonti, MD, Phone: 390226432706, Email: piemonti.lorenzo@hsr.it

IRCCS San Raffaele, Milan 20132, Italy; Recruiting
Gianpaolo Balzano, MD, Phone: 390226432664, Email: gianpaolo.balzano@hsr.it
Lorenzo Piemonti, MD, Phone: 390226432706, Email: lorenzo.piemonti@hsr.it
Additional Information

Starting date: July 2010
Last updated: March 4, 2015

Page last updated: August 20, 2015

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