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Completed

NCT Number: NCT07761975

Perioperative HALP and Surgical Outcomes

Esophagectomy is associated with substantial postoperative morbidity despite advances in perioperative care. The Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score has been proposed as a composite biomarker reflecting nutritional, inflammatory, and immune status; however, its perioperative behavior and clinical significance after esophagectomy remain unclear. This retrospective cohort study evaluates perioperative changes in HALP and examines the associations of preoperative, postoperative day 1, and postoperative day 7 HALP measurements with postoperative complications, including overall and major complications, anastomotic leakage, ICU readmission, and length of hospital stay. The study aims to clarify the potential role of perioperative HALP as a marker of postoperative recovery and adverse clinical outcomes following esophagectomy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

About this study

Esophagectomy remains the cornerstone of curative treatment for localized esophageal cancer but is associated with a high incidence of postoperative morbidity despite advances in surgical techniques and perioperative care. Early identification of patients at increased risk of postoperative complications remains an important objective in perioperative medicine, as timely recognition of physiological deterioration may facilitate closer monitoring and individualized postoperative management.

The Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score is a composite biomarker derived from routinely available laboratory parameters that integrates nutritional, inflammatory, hematologic, and immune status. Previous studies have primarily evaluated preoperative HALP as a prognostic indicator for long-term oncological outcomes in various malignancies. However, limited evidence is available regarding perioperative changes in HALP and whether postoperative HALP measurements provide clinically relevant information following major upper gastrointestinal surgery.

This retrospective cohort study evaluates perioperative HALP measurements obtained before surgery, on postoperative day 1, and on postoperative day 7 in patients undergoing esophagectomy. The study investigates perioperative HALP dynamics and examines the associations between HALP measurements at different time points and clinically relevant postoperative outcomes, including overall complications, major complications, anastomotic leakage, ICU readmission, and length of hospital stay.

The objective of this study is to characterize perioperative changes in HALP and to explore its potential role as a perioperative biomarker associated with postoperative recovery and adverse clinical outcomes after esophagectomy. Findings from this study may contribute to a better understanding of the temporal behavior of HALP following major surgery and inform future prospective studies evaluating its clinical utility in perioperative risk assessment and postoperative monitoring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Histologically confirmed esophageal cancer.
  • Underwent elective esophagectomy with curative intent between June 2020 and March 2025.
  • Available laboratory data for calculation of the Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score preoperatively and on postoperative days 1 and 7.
  • Complete clinical data regarding postoperative outcomes

Exclusion criteria

  • Age younger than 18 years.
  • Benign esophageal disease or surgery performed for indications other than esophageal cancer.
  • Emergency esophagectomy.
  • Missing laboratory data required for calculation of the HALP score at any of the predefined time points (preoperative, postoperative day 1, or postoperative day 7).
  • Incomplete clinical or follow-up data regarding postoperative outcomes.

Treatment and study plan

Perioperative HALP Score Assessment

Other

Assessment of the Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score using routinely collected laboratory measurements obtained preoperatively and on postoperative days 1 and 7. No intervention or treatment was assigned as part of the study.

Primary outcomes

  1. Incidence of postoperative complications

    Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 7 for HALP measurements; Postoperative complications - from the day of surgery to hospital discharge, with follow-up extending up to 101 days in the patient with the longest stay

    Incidence and severity of postoperative complications following esophagectomy, classified according to the Clavien-Dindo classification. HALP scores were measured at baseline (preoperatively) and on postoperative days 1 and 7 and were evaluated as predictors of postoperative complications. Postoperative complications were assessed from the day of surgery through hospital discharge.

Secondary outcomes

  1. Incidence of major postoperative complications (Clavien-Dindo grade III or higher)

    Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 7 for HALP measurements; Postoperative complications - from the day of surgery to hospital discharge, with follow-up extending up to 101 days in the patient with the longest stay

    Incidence of major postoperative complications, defined as Clavien-Dindo grade III or higher according to the Clavien-Dindo classification, following esophagectomy. Major complications will be identified from hospital records.

  2. Incidence of unplanned intensive care unit (ICU) readmission

    Time frame: From the day of surgery to hospital discharge, with follow-up extending up to 101 days in the patient with the longest stay

    Incidence of unplanned readmission to the intensive care unit following esophagectomy, determined from hospital medical records.

  3. Perioperative changes in HALP score

    Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 7 for HALP measurements

    To evaluate changes in HALP scores measured preoperatively and on postoperative days 1 and 7

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

Perioperative Changes in Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score and Postoperative Outcomes After Esophagectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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