Association Between Preoperative HALP and Immediate Postoperative Outcomes

August 16, 2022 updated by: Gaurav Katwal, Chitwan Medical College

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Bharatpur, Bagmati, Nepal, 44207
        • Chitwan Medical College Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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?)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chitwan Medical College

Investigators

  • Study Chair: Harish Neupane, MBBS, MS, Chitwan Medical Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 078/079-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD can be shared in view of the progress of medical research. An interested person should contact the primary investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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