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Not yet recruiting NCT07360119

Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors

No phase Interventional Periampullary Neoplasms Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Pancreatectomy with Islet Autotransplantation (TPIAT).
Who it may be relevant to
Registry conditions: Periampullary Neoplasms, Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Total Pancreatectomy With Islet Autotransplantation (TPIAT) for Patients With Periampullary Neoplasms at High Risk for Pancreaticojejunostomy Leakage After Pancreaticoduodenectomy: a Single-center, Prospective, Single-Arm, Observational Study

Overview

This is a single-center, prospective, single-arm study evaluating the safety and feasibility of total pancreatectomy with islet autotransplantation (TPIAT) in carefully selected adult patients with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy. Eligible patients will undergo open or robotic TPIAT as part of the patient's surgical management. Perioperative outcomes, postoperative complications, metabolic outcomes, and early oncologic outcomes will be collected prospectively as part of routine clinical care and analyzed to assess the safety and feasibility of this approach.

Interventions

  • Procedure Total Pancreatectomy with Islet Autotransplantation (TPIAT)
    This intervention involves a total pancreatectomy with subsequent islet autotransplantation for patients diagnosed with high-risk periampullary neoplasms. The procedure is performed following strict surgical protocols and includes resection of the pancreas while aiming to eliminate the risk of postoperative pancreatic fistula (POPF). Islet cells are isolated from the nontumorous pancreatic tissue and infused into the portal vein to maintain endocrine function, thus reducing the likelihood of bri

Primary outcome measures

  • Incidence of Postoperative Complications [Time frame: Within 90 days post-surgery.]
Secondary outcome measures (1)
  • Length of Hospital Stay [Time frame: Within 90 days post-surgery.]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 and older.
  • Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to:
  • Distal bile duct adenocarcinoma
  • Duodenal adenocarcinoma
  • Leiomyosarcoma of the duodenum
  • Pancreatic neuroendocrine neoplasms
  • Ampullary adenoma
  • Duodenal gastrointestinal stromal tumor (GIST)
  • High-risk Intraductal Papillary Mucinous Neoplasm (IPMN) as per Fukuoka criteria
  • Mucinous cystic neoplasm
  • Serous cystadenoma
  • Presence of soft pancreatic tissue and a main pancreatic duct ≤ 2 mm based on preoperative imaging.
  • Adequate islet function with measurable C-peptide preoperatively to justify islet isolation and transplant.

Exclusion criteria

  • Pregnancy
  • Active alcohol or illicit drug use
  • Poorly controlled psychiatric illness that limits compliance with care
  • Pre-existing insulin-dependent diabetes with absent C-peptide
  • Portal vein thrombosis or significant portal hypertension
  • Contraindications to major surgery
  • Body Mass Index (BMI) > 35 kg/m².

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07360119 · IRB00543437

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗