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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPIAT for Patients with High-Risk Periampullary Neoplasms | Experimental | This single-arm study investigates the outcomes of Total Pancreatectomy with Islet Autotransplantation (TPIAT) in patients diagnosed with high-risk periampullary neoplasms. The intervention aims to eliminate the risk of postoperative pancreatic fistula and preserve endocrine function, while assessing safety and feasibility. Participants will undergo TPIAT via either open or robotic surgical techniques, and various postoperative metrics will be evaluated over a 12-month period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Pancreatectomy with Islet Autotransplantation (TPIAT) | Procedure | 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 brittle diabetes post-surgery. Patient outcomes will be evaluated for safety, metabolic control, and overall quality of life over a 12-month follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Complications | The incidence of postoperative complications within 90 days following Total Pancreatectomy with Islet Autotransplantation (TPIAT) will be assessed. Complications will be defined and graded according to the Clavien-Dindo classification system. The goal is to evaluate the safety and feasibility of TPIAT in high-risk patients with periampullary neoplasms. | Within 90 days post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | This measure will track the total number of days patients remain hospitalized following TPIAT. The data will help evaluate the procedure's impact on recovery time. | Within 90 days post-surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas McPhaul | Contact | 410-614-7551 | tmcphau2@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jin He, MD | SKCCC Johns Hopkins Medical Institution | Principal Investigator |
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|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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