Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula

Официальное название

Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation (IAtx) in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula (POPF)

Обзор

The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.

Вмешательства

• Биопрепарат Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy
  Islet cells are isolated from patients healthy pancreatic tissue. Following total pancreatectomy, these autologous cells are injected into the portal vein, to implant in the liver and produce insulin.
• Процедура Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
  As a standard procedure, the tumor-affected region of the pancreatic head with surrounding tissue and lymph nodes is removed during surgery. Reconstruction is performed by pancreaticojejunostomy.

Первичные конечные точки

• Duration between surgery and time "fit for adjuvant treatment" (postoperative day X) [Срок оценки: From day of discharge until confirmed fitness for adjuvant treatment or 24 months, whichever came first]

Вторичные конечные точки (12)

• Comparison of actual start of adjuvant therapy in both arms [Срок оценки: From POD 90 until actual start of therapy or 24 months whichever came first]
• Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification [Срок оценки: After enrolment of the patient until 24 months after intervention]
• Rate of (serious) adverse events [Срок оценки: After randomization of the patient until 24 months after intervention]
• Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire [Срок оценки: From date of screening until 24 months after intervention]
• Patient reported outcomes: Quality of life EORTC PAN26 questionnaire [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM) [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: glucagon [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: C-peptide [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: fructosamine [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: insulin requirement [Срок оценки: From date of screening until 24 months after intervention]
• Comparison of metabolic outcome in both arms: number of hypoglycemic events [Срок оценки: From date of screening until 24 months after intervention]

Критерии участия

Критерии включения

• suspected or confirmed periampullary carcinoma (tumor) and indication for PPPD (pylorus-preserving pancreaticoduodenectomy) or Whipple surgery
• high-risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreas and Pancreatic duct diameter < 3 mm (preoperative and intraoperative confirmation)
• written informed consent of the participant after successful Informed consent

Критерии исключения

• patients on whom another procedure is to be performed simultaneously in addition to PPPD or Whipple surgery
• confirmed other primary tumor
• previous transplantation of an organ or tissue
• known infection with HIV (HIV antibodies)
• positive hepatitis C antibodies, positive hepatitis B surface antigens and hepatitis Bc antibodies
• insulin-treated diabetes mellitus
• history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure
• concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion).
• addiction or other medical conditions that do not allow the subject to understand the nature and not be able to appreciate the nature, scope and possible consequences of the trial
• pregnant or breastfeeding women
• women of childbearing age, except for women who meet the following criteria:

• Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
• Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)
• Regular and correct use of a contraceptive method with an failure rate < 1% per year
• Sexual abstinence
• Vasectomy of the partner
• evidence that the patient is unlikely to comply with the protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Hospital Carl Gustav Carus Technische Universität Dresden — Dresden

Публикации

• Hempel S, Kolbinger FR, Oehme F, Radulova-Mauersberger O, Schmid J, Schubert U, Schepp F, Bornstein S, Korn S, Trips E, Weitz J, Distler M, Ludwig B. Pancreatoduodenectomy versus total pancreatectomy and simultaneous intraportal islet autotransplantation for periampullary cancer at high-risk of postoperative pancreatic fistula (XANDTX-trial): Protocol of a randomized controlled pilot trial. PLoS O PMID 40720532

Идентификаторы

NCT: NCT05843877 · TUD-XandTX-079 · 2023-507773-17-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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