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临床试验/NCT05506748
NCT05506748已完成不适用

Association Between Preoperative HALP and Immediate Postoperative Outcomes in Patients Undergoing Pancreaticoduodenectomy

Chitwan Medical College1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Mortality

研究概览

简要总结

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor of postoperative survival. To date, no study has been done with preoperative HALP to predict 30days morbidity and mortality.

Is there any association between Preoperative HALP (hemoglobin, albumin, lymphocyte, and platelet) and 30 days post operative morbidity and mortality in patients undergoing Pancreaticoduodenectomy?

详细描述

General Objective:

To assess the association between preoperative HALP and immediate postoperative outcome among patients undergoing PD.

Specific Objectives:

  1. To identify the magnitude of immediate post-operative morbidity and mortality in patients undergoing PD.
  2. To evaluate the descriptive measurement of preoperative Hemoglobin, Albumin, Lymphocytes, Platelets and HALP among patients undergoing PD.
  3. To compare the preoperative HALP with morbidity and mortality among patients undergoing PD.

Operational Definition:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the cases of elective pancreaticoduodenectomies for malignant pancreatic head disease

排除标准

  • Incomplete clinicopathological and follow-up data,
  • Age <15 years and age >80 years
  • History of antitumor treatments, and
  • Record of other malignant tumors, (unresectable?)

结局指标

主要结局

Mortality

时间窗: 30days following the pancreaticoduodenectomy

Survival within 30days.

Morbidity- Clavién-Dindo grading :

时间窗: 30days following the pancreaticoduodenectomy

It is graded from grade I to V on the basis of surgical site infection, organ space infection, single or multiple organ failure, and death. Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II Requires pharmacological treatment, blood transfusions, or total parenteral nutrition Grade III Requires surgical, endoscopic, or radiological intervention IIIa Not under general anesthesia IIIb Under general anesthesia Grade IV Life-threatening complication requiring IC/ICU management IVa Single organ dysfunction IVb Multiorgan dysfunction Grade V Death of a patient PS- Higher the score worst the outcome.

Morbidity- Postoperative pancreatic fistula (POPF)

时间窗: 30days following the pancreaticoduodenectomy

A POPF is an abnormal communication between the pancreatic ductal epithelium and another epithelial surface containing pancreas-derived enzyme-rich fluid. Biochemical leak (Grade A): Pancreatic fistula often appears well and requires no intervention. Grade B: Pancreatic fistulas occur in patients who generally appear well, but may require parenteral nutrition or interventional fistula drainage for the fistula to heal. Grade C: Pancreatic fistulas, in which patients appear ill and require parenteral nutrition, interventional drainage, and potentially even re-operation for treatment. PS- Higher the score worst the outcome.

Morbidity- Delayed Gastric Empty (DGE)

时间窗: 30days following the pancreaticoduodenectomy

Postoperative gastroparesis. Grade A DGE: If the Naso-Gastric Tube (NGT) is needed between the postoperative day (POD) -4 and 7, or if reinserted due to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but starts a solid diet before POD 14. Grade B DGE: If the NGT is needed from POD 8-14, if reinserted after POD 7, or if the patient cannot tolerate unlimited oral intake by POD 14, but is able to resume a solid diet before POD 21. Grade C DGE: When nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21. PS- Higher the score worst the outcome.

Morbidity- Post pancreatectomy Hemorrhage (PPH)

时间窗: 30days following the pancreaticoduodenectomy

Time of onset * Early hemorrhage ( 24 h after the end of the index operation) * Late hemorrhage ( 24 h after the end of the index operation) Location * Intraluminal * Extraluminal Severity of Hemorrhage Mild * Small or medium volume blood loss (from drains, nasogastric tube, or on ultrasonography, decrease in hemoglobin concentration 3 g/dl) * Mild clinical impairment of the patient, no therapeutic consequence, or at most the need for noninvasive treatment with volume resuscitation or blood transfusions (2-3 units packed cells within 24hrs of end of operation or 1-3 units if later than 24hrs after operation) * No need for reoperation or interventional angiographic embolization; endoscopic treatment of anastomotic bleeding may occur provided the other conditions apply Severe * Large volume blood loss (drop in hemoglobin level by 3g/dl) * Clinically significant impairment and need for blood transfusion (3 units packed cells) * Need for invasive treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaurav Katwal

Principal Investigator

Chitwan Medical College

研究点 (1)

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