EsophagectomyNCT07761975
Perioperative HALP and Surgical Outcomes
An observational study of Esophagectomy and HALP Score, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, HALP Score, Perioperative Biomarkers
- What is being tested?
- Perioperative HALP Score Assessment
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 22 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, 34480
About this study
Official title: Perioperative Changes in Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score and Postoperative Outcomes After Esophagectomy
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.
Read the detailed description
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.
- Conditions
- Esophagectomy, HALP Score, Perioperative Biomarkers, Postoperative Complications, Perioperative Risk Assessment
- Being tested
- Perioperative HALP Score Assessment
- Keywords
- Esophagectomy, HALP score, Perioperative biomarkers, Postoperative complications, Perioperative Risk Assessment
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative HALP Score AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Perioperative HALP Score Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Incidence of unplanned readmission to the intensive care unit following esophagectomy, determined from hospital medical records.
Measured: 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
To evaluate changes in HALP scores measured preoperatively and on postoperative days 1 and 7
Measured: Baseline (preoperative), postoperative day 1, and postoperative day 7 for HALP measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start10 Jun 2026
- Primary completion15 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
- Investigators
- Hürü Ceren Gökduman, MD, Principal investigator, Basaksehir Cam ve Sakura State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761975
- Sponsor's protocol ID
- 2026-206
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Changes in Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score and Postoperative Outcomes After Esophagectomy
- ClinicalTrials.gov ID
- NCT07761975
- Acronym / sponsor ID
- 2026-206
- Conditions
- Esophagectomy, HALP Score, Perioperative Biomarkers, Postoperative Complications, Perioperative Risk Assessment
- Keywords
- Esophagectomy, HALP score, Perioperative biomarkers, Postoperative complications, Perioperative Risk Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Esophagectomy | – | Other: Perioperative HALP Score AssessmentAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative HALP Score AssessmentAssessment 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. | Other | Patients Undergoing Esophagectomy |
Primary outcome
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.
3 secondary outcomes
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 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
Perioperative changes in HALP score
Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 7 for HALP measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hürü Ceren Gökduman, MD principal investigator
Basaksehir Cam ve Sakura State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy and HALP Score, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.