Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis

NCT01346098 | Completed Phase 2 DMC

• 1 other identifier: PAN-IT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpancreatectomy Hyperglycemia

Keywords

diabetes; islet transplantation; pancreas; pancreatectomy

Outcome Measures

Primary Outcomes (1)

• incidence of complications after pancreatic surgery

  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.

  90 days from discharge

Secondary Outcomes (2)

• Incidence of each individual postoperative complication

  90 days from discharge

• Incidence of endocrine and exocrine pancreatic insufficiency

  12 months after surgery.

Study Arms (2)

GROUP B

EXPERIMENTAL

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

GROUP A

ACTIVE COMPARATOR

Procedure: Pancreaticoduodenectomy with pancreatic anastomosis

Interventions

Pancreaticoduodenectomy with pancreatic anastomosis PROCEDURE

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

GROUP A

Total pancreatectomy with islet autotransplantation PROCEDURE

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.

GROUP B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale San Raffaele: lead
• Ministry of education, university and research, Italy: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

• Balzano G, Zerbi A, Aleotti F, Capretti G, Melzi R, Pecorelli N, Mercalli A, Nano R, Magistretti P, Gavazzi F, De Cobelli F, Poretti D, Scavini M, Molinari C, Partelli S, Crippa S, Maffi P, Falconi M, Piemonti L. Total Pancreatectomy With Islet Autotransplantation as an Alternative to High-risk Pancreatojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Trial. Ann Surg. 2023 Jun 1;277(6):894-903. doi: 10.1097/SLA.0000000000005713. Epub 2022 Sep 30.

  PMID: 36177837 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Lorenzo Piemonti, MD

  Fondazione Centro San Raffaele del Monte Tabor

  PRINCIPAL INVESTIGATOR

• Gianpaolo Balzano, MD

  Fondazione Centro San Raffaele del Monte Tabor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Islet Transplantation Program

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

IT (1)