- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346098
Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis (PAN-IT)
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 Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Milan, Italy, 20132
- IRCCS San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GROUP B
At the time of surgery the surgeon will directly assess pancreatic consistency and the pancreatic duct size.
In the presence of a soft pancreas and a small duct (diameter <3 mm), the patient will be randomly assigned to receive either a pancreaticoduodenectomy with pancreatic anastomosis (group A) or a total pancreatectomy with IAT (group B).
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If the patient will be assigned to this group, the surgeon will complete the pancreatectomy preserving the spleen.
The body and tail of the pancreas will be sent to the islet isolation facility.
Islets will be isolated and purified according to the automated method described by Ricordi.
The resulting islet tissue will be suspended in a cold isotonic saline solution and infused into the portal vein during the next 24h.
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Active Comparator: GROUP A
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Standard lymphadenectomy, end-to-side two-layer pancreaticojejunostomy and duodenojejunostomy will be performed.
If the pylorus is preserved, so will be the right gastric artery, unless the artery is damaged or hindering adequate gastric mobilization.
No prokinetic agent will be administered routinely, but IV metoclopramide will given on demand (10 mg , three times daily).
Prophylaxis will consist of octreotide (0,1 mg three times daily from day 0 to 7), low molecular weight heparin and a single dose of antibiotic (cefazolin 2 g).
Early postoperative analgesia will be achieved by epidural or, when contraindicated, patient-controlled analgesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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incidence of complications after pancreatic surgery
Time Frame: 90 days from discharge
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Complications will be defined and graded according to the Novel Grading System classification ( DeOliveira et al 2006).
A special emphasis is given to life-threatening and permanently disabling complications.
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90 days from discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of each individual postoperative complication
Time Frame: 90 days from discharge
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90 days from discharge
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Incidence of endocrine and exocrine pancreatic insufficiency
Time Frame: 12 months after surgery.
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We will assess endocrine pancreatic function by measuring fasting plasma glucose and HbA1c in all patients. Clinical hallmarks of pancreatic exocrine insufficiency include symptoms of fat malabsorption, such as steatorrhea, weight loss and abdominal pain. Frequency of bowel movements and characteristics of stools will be serially recorded. Fat-soluble vitamins such as A, D, E and K will be measured 12 month after the hospital discharge after the index surgery. Oral pancreatic enzyme supplementation will be prescribed according to the severity of clinical steatorrhea and weight loss. |
12 months after surgery.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorenzo Piemonti, MD, Fondazione Centro San Raffaele del Monte Tabor
- Study Director: Gianpaolo Balzano, MD, Fondazione Centro San Raffaele del Monte Tabor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAN-IT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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