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Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis (PAN-IT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Ospedale San Raffaele
Ministry of education, university and research, Italy
Information provided by (Responsible Party):
Piemonti Lorenzo, Ospedale San Raffaele Identifier:
First received: April 29, 2011
Last updated: June 14, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Postpancreatectomy Hyperglycemia
Procedure: Pancreaticoduodenectomy with pancreatic anastomosis
Procedure: Total pancreatectomy with islet autotransplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Ospedale San Raffaele:

Primary Outcome Measures:
  • incidence of complications after pancreatic surgery [ Time Frame: 90 days from discharge ]
    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.

Secondary Outcome Measures:
  • Incidence of each individual postoperative complication [ Time Frame: 90 days from discharge ]
    1. death
    2. pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005)
    3. delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007)
    4. intra-abdominal complications
    5. medical complications

  • Incidence of endocrine and exocrine pancreatic insufficiency [ Time Frame: 12 months after surgery. ]

    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.

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Procedure: Total pancreatectomy with islet autotransplantation
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.
Active Comparator: GROUP A Procedure: Pancreaticoduodenectomy with pancreatic anastomosis
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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01346098

Contact: Lorenzo Piemonti, MD 390226432706
Contact: Gianpaolo Balzano, MD 390226432664

IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Gianpaolo Balzano, MD    390226432664   
Contact: Lorenzo Piemonti, MD    390226432706   
Sponsors and Collaborators
Ospedale San Raffaele
Ministry of education, university and research, Italy
Principal Investigator: Lorenzo Piemonti, MD Fondazione Centro San Raffaele del Monte Tabor
Study Director: Gianpaolo Balzano, MD Fondazione Centro San Raffaele del Monte Tabor
  More Information

Responsible Party: Piemonti Lorenzo, Director Islet Transplantation Program, Ospedale San Raffaele Identifier: NCT01346098     History of Changes
Other Study ID Numbers: PAN-IT
Study First Received: April 29, 2011
Last Updated: June 14, 2016

Keywords provided by Ospedale San Raffaele:
islet transplantation

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Gastrointestinal Agents processed this record on May 25, 2017