Impact of Preserving Versus Ligating the Right Gastric Artery on Anastomotic Outcomes After McKeown Esophagectomy: A Randomized Controlled Trial

January 15, 2026 updated by: Yongbin Song, The First Hospital of Hebei Medical University
This randomized controlled trial evaluates the impact of preserving versus ligating the Right Gastric Artery (RGA) on postoperative anastomotic complications in patients undergoing McKeown minimally invasive esophagectomy (MIE) for esophageal squamous cell carcinoma. Specifically, the study compares the incidence of anastomotic leakage and stenosis between two groups of patients reconstructed with a 3cm-wide gastric conduit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anastomotic leakage (AL) and benign anastomotic stenosis (BAS) are critical complications following McKeown MIE. While the right gastroepiploic artery (RGEA) is the primary blood supply for the gastric conduit, the role of the Right Gastric Artery (RGA) remains controversial. Some evidence suggests preserving the RGA may improve perfusion to the proximal gastric conduit, potentially reducing ischemic complications. In this single-center prospective RCT, 120 eligible patients were randomized 1:1 into an RGA Preservation Group (Group A) and an RGA Ligation Group (Group B). Both groups underwent reconstruction with a narrow (3cm) gastric conduit. The study aims to provide evidence on whether RGA preservation improves hemodynamic outcomes as manifested by reduced leakage and stenosis rates.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Hebei General 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the middle or upper thoracic esophagus.
  • Candidates for elective McKeown minimally invasive esophagectomy (MIE).
  • Age 18-75 years.
  • Preoperative clinical stage I-IIIA (cT1-3N0-1M0) according to the AJCC/UICC 8th Edition TNM staging system.

Exclusion Criteria:

  • Clinical stage IIIB or IV.
  • History of previous thoracic or abdominal surgery affecting the stomach or esophagus.
  • Neoadjuvant chemoradiotherapy (to eliminate confounding effects on tissue healing).
  • Severe comorbidities (e.g., uncontrolled diabetes, severe cardiopulmonary dysfunction, liver cirrhosis).
  • Intraoperative finding of unresectable tumor.
  • Conversion to open surgery.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RGA Preservation Group
Patients in this arm underwent McKeown MIE where the stomach was mobilized while carefully preserving the main trunk of the right gastric artery (RGA). Lymph nodes along the lesser curvature (Station 3) were dissected by peeling them away from the vascular arcade.
Procedure: McKeown MIE with RGA Preservation
Patients in this arm underwent McKeown MIE where the stomach was mobilized while carefully preserving the main trunk of the right gastric artery (RGA). Lymph nodes along the lesser curvature (Station 3) were dissected by peeling them away from the vascular arcade.
Active Comparator: RGA Ligation Group
Patients in this arm underwent McKeown MIE where the right gastric artery (RGA) was identified at its origin from the proper hepatic artery and ligated at the root to facilitate en bloc resection of Station 3 lymph nodes.
Procedure: McKeown MIE with RGA Ligation
Patients in this arm underwent McKeown MIE where the right gastric artery (RGA) was identified at its origin from the proper hepatic artery and ligated at the root to facilitate en bloc resection of Station 3 lymph nodes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Cervical Anastomotic Leakage
Time Frame: Up to 30 days postoperatively
Defined as the extravasation of contrast on esophagogram or the presence of saliva/gastric content in the cervical wound, often accompanied by fever or inflammatory signs.
Up to 30 days postoperatively
Incidence of Anastomotic Stenosis (Early)
Time Frame: 2 months postoperatively
Assessment of benign anastomotic stenosis (BAS) via gastroscopy and contrast swallow. Stenosis was graded based on luminal diameter and dysphagia symptoms.
2 months postoperatively
Incidence of Anastomotic Stenosis (Late)
Time Frame: 4 months postoperatively
Assessment of benign anastomotic stenosis (BAS) via gastroscopy and contrast swallow. Stenosis was graded based on luminal diameter and dysphagia symptoms.
4 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: Day 1 (Day of Surgery)
The total duration of the surgical procedure measured in minutes.
Day 1 (Day of Surgery)
Lymph Node Yield
Time Frame: Day 1 (Day of Surgery)
The total count of lymph nodes harvested during the surgery.
Day 1 (Day of Surgery)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Hebei Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200507

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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