Association Between Preoperative HALP and Immediate Postoperative Outcomes

Study Overview
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Brief Summary
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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?

Detailed Description
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General Objective: To assess the association between preoperative HALP and immediate postoperative outcome among patients undergoing PD. Specific Objectives: To identify the magnitude of immediate post-operative morbidity and mortality in patients undergoing PD. To evaluate the descriptive measurement of preoperative Hemoglobin, Albumin, Lymphocytes, Platelets and HALP among patients undergoing PD. To compare the preoperative HALP with morbidity and mortality among patients undergoing PD. Operational Definition: Immediate postoperative time - was taken as 30days following surgery. Morbidity- was defined by Clavién-Dindo20 grading for the surgical complication and DGE,21 POPF,22 and PPH23 -according to International Study Group of Pancreatic Surgery (ISGPS) grading. Mortality- survival within 30days. Level of preoperative HALP- normality test was done via SPSS and data of HALP followed normal Gaussian distribution. So, mean was used for the calculation of cut off value as 35.83. And, patients were divided into low HALP (≤35.83) group and high HALP (>35.83) group respectively

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

Conditions
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Hemoglobins, Albumins, Platelets, Lymphocytes, Morbidity, Mortality, Whipples Procedure

Intervention / Treatment
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* Other: pantients undergoing pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All the cases of elective pancreaticoduodenectomies for malignant pancreatic head disease Exclusion Criteria: Incomplete clinicopathological and follow-up data, Age <15 years and age >80 years History of antitumor treatments, and Record of other malignant tumors, (unresectable?)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pantients undergoing pancreaticoduodenectomy|The study includes all the cases who underwent pancreaticoduodenectomy for carcinoma head of the pancreas, distal cholangiocarcinoma, periampullary and duodenal cancer.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity- Clavién-Dindo grading : | 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. | 30days following the pancreaticoduodenectomy | 
| Morbidity- Delayed Gastric Empty (DGE) | 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. | 30days following the pancreaticoduodenectomy | 
| Morbidity- Postoperative pancreatic fistula (POPF) | 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. | 30days following the pancreaticoduodenectomy | 
| Morbidity- Post pancreatectomy Hemorrhage (PPH) | 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. | 30days following the pancreaticoduodenectomy | 
| Mortality | Survival within 30days. | 30days following the pancreaticoduodenectomy |