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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Annual accrual rate of participants who consent to and undergo planned TPIAT
研究概览
简要总结
This is a single-center, prospective, single-arm feasibility study evaluating whether adult patients with periampullary neoplasms who are at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy can be recruited and consented to undergo total pancreatectomy with islet autotransplantation as an alternative surgical approach. Feasibility will be assessed by annual accrual rate and consent yield among eligible patients approached. Participants who enroll will undergo open or robotic total pancreatectomy with islet autotransplantation. Perioperative safety, metabolic outcomes, and early oncologic outcomes will be collected prospectively through 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older.
- •Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to:
- •Pancreatic adenocarcinoma
- •Distal bile duct adenocarcinoma
- •Duodenal adenocarcinoma
- •Leiomyosarcoma of the duodenum
- •Pancreatic neuroendocrine neoplasms
- •Ampullary adenoma
- •Duodenal gastrointestinal stromal tumor
- •High-risk intraductal papillary mucinous neoplasm according to Fukuoka criteria, specifically focal Intraductal Papillary Mucinous Neoplasm (IPMN) in the head of pancreas with high-risk stigmata or worrisome features on endoscopic ultrasound with fine-needle aspiration
- •Mucinous cystic neoplasm
- •Serous cystadenoma
- •Soft pancreatic gland and main pancreatic duct ≤2 mm at the neck of the pancreas based on preoperative imaging.
- •Adequate islet function with measurable C-peptide preoperatively to justify islet isolation and transplant.
排除标准
- •Pregnancy.
- •Active alcohol or illicit drug use.
- •Poorly controlled psychiatric illness that limits ability to comply with care.
- •Pre-existing insulin-dependent diabetes with absent C-peptide.
- •Portal vein thrombosis or significant portal hypertension precluding islet infusion.
- •Contraindications to major surgery.
- •Body mass index greater than 35 kg/m².
研究组 & 干预措施
Total Pancreatectomy With Islet Autotransplantation
Participants with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy will undergo total pancreatectomy with islet autotransplantation using either an open or robotic surgical approach. Outcomes will be assessed prospectively through 12 months after surgery.
干预措施: Total Pancreatectomy with Islet Autotransplantation (TPIAT) (Procedure)
结局指标
主要结局
Annual accrual rate of participants who consent to and undergo planned TPIAT
时间窗: From study opening through completion of enrollment, up to 36 months
Annual accrual rate, defined as the number of eligible participants per year who provide informed consent and proceed with the planned total pancreatectomy with islet autotransplantation procedure. The feasibility threshold is accrual of at least 3 participants per year.
Consent yield among eligible patients approached for participation
时间窗: From study opening through completion of enrollment, up to 36 months
Consent yield, defined as the proportion of approached, eligible patients who provide informed consent and undergo planned total pancreatectomy with islet autotransplantation. The feasibility threshold is at least 5%, defined as at least 1 of the first 20 eligible patients approached consenting to and undergoing TPIAT.
Incidence of Postoperative Complications
时间窗: Within 90 days post-surgery.
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.
次要结局
- Incidence of major postoperative complications within 90 days after surgery(Up to 90 days post surgery)
- Unplanned readmission within 90 days after surgery(Up to 90 days post surgery)
- Length of hospital stay(From date of surgery to date of discharge, assessed up to 90 days)
- Incidence of hypoglycemic events requiring hospitalization(Up to 12 months post surgery)
- Incidence of endocrine pancreatic insufficiency(At 3, 6, and 12 months post surgery)
- Average Daily Insulin requirement (IU/kg/day) after TPIAT(At 3, 6, and 12 months post surgery)
- Fasting glucose (percentage) after TPIAT(At 3, 6, and 12 months post surgery)
- Fasting C-peptide (ng/mL) after TPIAT(At 3, 6, and 12 months after surgery)
- Hemoglobin A1c (percentage) after TPIAT(At 3, 6, and 12 months after surgery)
- Tumor recurrence within 1 year after surgery(Within 12 months after surgery)
- Length of Hospital Stay(Within 90 days post-surgery.)