NCT07761975

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

July 23, 2026

Last Update Submit

August 8, 2026

Conditions

Keywords

EsophagectomyHALP scorePerioperative biomarkersPostoperative complicationsPerioperative Risk Assessment

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative complications

    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.

    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

Secondary Outcomes (3)

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

    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 unplanned intensive care unit (ICU) readmission

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

  • Perioperative changes in HALP score

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

Study Arms (1)

Patients Undergoing Esophagectomy

Adult patients who underwent elective esophagectomy for esophageal cancer at a single tertiary referral center between June 2020 and March 2025. Patients with available perioperative laboratory measurements required for calculation of the Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score before surgery and on postoperative days 1 and 7 were included in the retrospective cohort.

Other: Perioperative HALP Score Assessment

Interventions

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.

Patients Undergoing Esophagectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective cohort study included adult patients who underwent elective esophagectomy with curative intent for histologically confirmed esophageal cancer at a single tertiary referral center between June 2020 and March 2025. Patients with available perioperative laboratory data for calculation of the Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score before surgery and on postoperative days 1 and 7 were included.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hürü Ceren Gökduman, MD

    Basaksehir Cam ve Sakura State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 13, 2026

Study Start

June 10, 2026

Primary Completion

July 15, 2026

Study Completion

July 22, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study contains patient-level clinical data collected retrospectively, and data sharing is restricted by institutional policies and patient confidentiality requirements.

Locations