Postpancreatectomy HyperglycemiaPhase 2PAN-ITNCT01346098
Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis
A Phase 2 study testing Pancreaticoduodenectomy with pancreatic anastomosis and Total pancreatectomy with islet autotransplantation in people with Postpancreatectomy Hyperglycemia, run by Ospedale San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpancreatectomy Hyperglycemia
- What is being tested?
- Pancreaticoduodenectomy with pancreatic anastomosis and Total pancreatectomy with islet autotransplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Postpancreatectomy Hyperglycemia
- Being tested
- Pancreaticoduodenectomy with pancreatic anastomosis, Total pancreatectomy with islet autotransplantation
- Keywords
- diabetes, islet transplantation, pancreas, pancreatectomy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticoduodenectomy with pancreatic anastomosisProcedure or surgery
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
Total pancreatectomy with islet autotransplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Total pancreatectomy with islet autotransplantation |
| GROUP A | Active comparator | Not described Receives: Procedure: Pancreaticoduodenectomy with pancreatic anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days from discharge
Secondary outcomes (2)
Incidence of each individual postoperative complication
- death
- pancreatic fistula defined according to the International Study Group on Pancreatic Fistula (Bassi C et al 2005)
- delayed gastric emptying (DGE) defined according to the International Study Group on Pancreatic Fistula (Wente et al 2007)
- intra-abdominal complications
- medical complications
Measured: 90 days from discharge
Incidence of endocrine and exocrine pancreatic insufficiency
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.
Measured: 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpancreatectomy HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Responsible party
- Principal investigator, Piemonti Lorenzo, Ospedale San Raffaele
- Investigators
- Lorenzo Piemonti, MD, Principal investigator, Fondazione Centro San Raffaele del Monte TaborGianpaolo Balzano, MD, Study director, Fondazione Centro San Raffaele del Monte Tabor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346098
- Sponsor's protocol ID
- PAN-IT
- Acronym
- PAN-IT
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2011
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36177837
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01346098
- Acronym / sponsor ID
- PAN-IT / PAN-IT
- Conditions
- Postpancreatectomy Hyperglycemia
- Keywords
- diabetes, islet transplantation, pancreas, pancreatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP B | Experimental | Procedure: Total pancreatectomy with islet autotransplantationAt 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). |
| GROUP A | Active comparator | Procedure: Pancreaticoduodenectomy with pancreatic anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreaticoduodenectomy with pancreatic anastomosisStandard 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 | Procedure or surgery | GROUP A |
| Total pancreatectomy with islet autotransplantationIf 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. | Procedure or surgery | GROUP B |
Primary outcome
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.
2 secondary outcomes
Incidence of each individual postoperative complication
Time frame: 90 days from discharge
Incidence of endocrine and exocrine pancreatic insufficiency
Time frame: 12 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 36177837Balzano 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Piemonti, MD principal investigator
Fondazione Centro San Raffaele del Monte Tabor
Gianpaolo Balzano, MD study director
Fondazione Centro San Raffaele del Monte Tabor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pancreaticoduodenectomy with pancreatic anastomosis and Total pancreatectomy with islet autotransplantation in people with Postpancreatectomy Hyperglycemia, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complications after pancreatic surgery (time frame: 90 days from discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.