Clinical trial NCT05506748: Association Between Preoperative HALP and Immediate Postoperative Outcomes
Official title: Association Between Preoperative HALP and Immediate Postoperative Outcomes in Patients Undergoing Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobins
Albumins
Platelets
Lymphocytes
Morbidity
Mortality
Whipples Procedure
Lead sponsor: Chitwan Medical College
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 22
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the cases of elective pancreaticoduodenectomy with combined "Artery First with Posterior and Uncinate approach" for malignant pancreatic head disease (ampullary, HOP, dCCA, duodenal In the Department of Surgery at BPKMCH between April 2021 to April 2022.

Brief summary: 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: 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:

1. Immediate postoperative time - was taken as 30days following surgery.
2. 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.
3. Mortality- survival within 30days.
4. 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

Eligibility criteria: Inclusion Criteria:

1. All the cases of elective pancreaticoduodenectomies for malignant pancreatic head disease

Exclusion Criteria:

1. Incomplete clinicopathological and follow-up data,
2. Age \<15 years and age \>80 years
3. History of antitumor treatments, and
4. Record of other malignant tumors, (unresectable?)

Primary outcomes:
measure: Morbidity- Clavién-Dindo grading :
timeFrame: 30days following the pancreaticoduodenectomy
measure: Morbidity- Delayed Gastric Empty (DGE)
timeFrame: 30days following the pancreaticoduodenectomy
measure: Morbidity- Postoperative pancreatic fistula (POPF)
timeFrame: 30days following the pancreaticoduodenectomy
measure: Morbidity- Post pancreatectomy Hemorrhage (PPH)
timeFrame: 30days following the pancreaticoduodenectomy
measure: Mortality
timeFrame: 30days following the pancreaticoduodenectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Bharatpur
country: Nepal
facility: Chitwan Medical College Teaching Hospital
state: Bagmati
Study officials:
affiliation: Chitwan Medical Hospital
name: Harish Neupane, MBBS, MS
role: STUDY_CHAIR
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