Chitwan Medical College Teaching Hospital
Bharatpur, Bagmati, 44207, Nepal
NCT Number: NCT05506748
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?
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Notify Me15 year–80 year
All sexes
Observational
Bharatpur, Bagmati, 44207, Nepal
General Objective:
To assess the association between preoperative HALP and immediate postoperative outcome among patients undergoing PD.
Specific Objectives:
Operational Definition:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study includes all the cases who underwent pancreaticoduodenectomy for carcinoma head of the pancreas, distal cholangiocarcinoma, periampullary and duodenal cancer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30days following the pancreaticoduodenectomy
Time of onset
Location
Severity of Hemorrhage Mild
Severe
Time frame: 30days following the pancreaticoduodenectomy
Survival within 30days.
Chitwan Medical College
Other
Association Between Preoperative HALP and Immediate Postoperative Outcomes in Patients Undergoing Pancreaticoduodenectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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