2024-517877-26-00招募中3 期
Perioperative hydrocortisone treatment in pancreatoduodenectomy – randomised double-blinded placebo-controlled interventional trial (PD-HYDRA)
Universitaetsklinikum Schleswig-Holstein AöR14 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2025年3月7日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 614
- 试验地点
- 14
- 主要终点
- 1. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)
研究概览
简要总结
- to assess the efficacy of the treatment strategy with hydrocortisone infusions in comparison to placebo. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with planned elective PD [pancreatoduodenectomy]; regardless of indication
- •Male or female patients aged ≥ 18 years without upper age limit
- •Written informed consent obtained according to international guidelines and local laws
- •Ability to understand the nature of the trial and the trial related procedures and to comply with them
排除标准
- •Other perioperatively planned or pre-existing medication with a glucocorticoid in a dose of more than 30mg hydrocortisone-equivalent per day (e.g. for PONV prophylaxis, autoimmune diseases)
- •Focal or generalized epilepsy
- •Untreated overt hypothyroidism (Elevated Thyroid-Stimulating Hormone (TSH) levels and Low Free Thyroxine (FT4) levels)
- •Vaccination with live vaccine or live attenuated vaccine within the 4 weeks prior to surgery
- •Pheochromocytoma
- •Known or persistent abuse of medication, drugs or alcohol
- •Person who is in a relationship of dependence/employment with the sponsor or the investigator
- •Current or planned pregnancy, nursing period
- •For women of childbearing potential failure to use one of the following safe methods of contraception: abstinence from sexual intercourse, female condoms, diaphragm or coil, each used in combination with spermicides; copper intra-uterine device
- •Known hypersensitivity to the IMP (hydrocortisone or any of the excipients)
- •Participation in any other interventional clinical trial within the last 30 days prior to surgery
- •Inherited thromboembolic disease (Factor V Leiden Mutation, Prothrombin gene mutation, Protein C-, Protein S-, or antithrombin deficiency),
- •Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
- •Patient without legal capacity
- •Uncontrolled arterial hypertension ESH Grade 3 (blood pressure remains at or above 180/110 mmHg despite treatment)
- •Chronic heart failure of New York Heart Association (NYHA) class III or IV
- •WOCBP using hormonal contraceptives.
- •Myasthenia gravis
- •Active gastric or duodenal ulcer disease
- •Active diverticulitis
- •Active ulcerative colitis
- •Recent onset (6 months before randomisation) active deep venous thrombosis
- •Recent onset (6 months before randomisation) thromboembolic disease
- •GFR < 30 ml/h/1.73 m² as estimated by CKD-EPI Creatinine Equation (2021) (www.kidney.org/professionals/gfr_calculator)
结局指标
主要结局
1. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)
1. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)
次要结局
- (Serious) adverse events ((S)AE)
- 2. POPF B/C within 90 days after pancreatoduodenectomy
- 3. Overall survival within one year (OS)
- 4. Grade IIIb or worse complication in the Clavien-Dindo Classification (CDC) within 90 days after surgery (CDC IIIb+)
- 6. Grade C postpancreatectomy haemorrhage within 90 days after surgery (PPH C)
- 7. Grade B or worse delayed gastric emptying within 90 days after surgery (DGE B/C)
- 8. Grade B or worse bile leak within 90 days after surgery (BL B/C)
- 9. Grade B or worse chyle leak within 90 days after surgery (CL B/C)
- 10. Completion pancreatectomy within 90 days after surgery
- 11. Surgical site infection within 90 days after surgery
- 12. Pneumonia within 90 days after first dose
- 13. Cholangitis within 90 days after first dose
- 5. Grade B or worse postpancreatectomy acute pancreatitis within 90 days after surgery (PPAP B/C)
研究者
Coordinating Investigator
Scientific
Universitaetsklinikum Schleswig-Holstein AöR
研究点 (14)
Loading locations...
相似试验
招募中
4 期
Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)PancreatitisDuodenal CarcinomaCholangio CarcinomaNCT07262957Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)400
进行中（未招募）
4 期
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery ComplicationsPancreatic FistulaPancreatic NeoplasmsNCT02775227Helsinki University Central Hospital126
招募中
2/3 期
Study on effectiveness of Hydrocortisone in reducing complications of pancreatic surgeryCTRI/2023/07/055280Dr Anantha Krishna V R128
招募中
3 期
Low dose corticosteroids adjacent to enzyme replacement therapy or chaperon therapy in patients with cardiac manifestation of Fabry diseaseFabry disease2025-521408-24-00Medical University Of Lodz40
招募中
2 期
Partial or total removal of the pancreas and transplantation of the patient's own islet cells in patients with pancreatic cancer and a high risk to develop fistulas (leaks) after surgery2023-507773-17-00Technische Universitat Dresden32