Clinical trial NCT01346098: Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpancreatectomy Hyperglycemia
Keywords: diabetes
islet transplantation
pancreas
pancreatectomy
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Ministry of education, university and research, Italy
First posted: 2011-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: incidence of complications after pancreatic surgery
timeFrame: 90 days from discharge
Secondary outcomes:
measure: Incidence of each individual postoperative complication
timeFrame: 90 days from discharge
measure: Incidence of endocrine and exocrine pancreatic insufficiency
timeFrame: 12 months after surgery.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: Fondazione Centro San Raffaele del Monte Tabor
name: Lorenzo Piemonti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Centro San Raffaele del Monte Tabor
name: Gianpaolo Balzano, MD
role: STUDY_DIRECTOR
References: