Esophageal Squamous Cell CarcinomaNCT07363629
Impact of Preserving Versus Ligating the Right Gastric Artery on Anastomotic Outcomes After McKeown Esophagectomy: A Randomized Controlled Trial
A study testing McKeown MIE with RGA Preservation and McKeown MIE with RGA Ligation in people with Esophageal Squamous Cell Carcinoma, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- McKeown MIE with RGA Preservation and McKeown MIE with RGA Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Nov 2020
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- McKeown MIE with RGA Preservation, McKeown MIE with RGA Ligation
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKeown MIE with RGA PreservationProcedure or surgery
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.
McKeown MIE with RGA LigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| RGA Preservation Group | Experimental | 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. Receives: Procedure: McKeown MIE with RGA Preservation |
| RGA Ligation Group | Active comparator | 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. Receives: Procedure: McKeown MIE with RGA Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cervical Anastomotic Leakage
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.
Measured: Up to 30 days postoperatively
Incidence of Anastomotic Stenosis (Early)
Assessment of benign anastomotic stenosis (BAS) via gastroscopy and contrast swallow. Stenosis was graded based on luminal diameter and dysphagia symptoms.
Measured: 2 months postoperatively
Incidence of Anastomotic Stenosis (Late)
Assessment of benign anastomotic stenosis (BAS) via gastroscopy and contrast swallow. Stenosis was graded based on luminal diameter and dysphagia symptoms.
Measured: 4 months postoperatively
Secondary outcomes (2)
Operative Time
The total duration of the surgical procedure measured in minutes.
Measured: Day 1 (Day of Surgery)
Lymph Node Yield
The total count of lymph nodes harvested during the surgery.
Measured: Day 1 (Day of Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jun 2018
- Primary completion31 Jul 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongbin Song, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363629
- Sponsor's protocol ID
- 20200507
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preserving Versus Ligating the Right Gastric Artery on Anastomotic Outcomes After McKeown Esophagectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07363629
- Acronym / sponsor ID
- 20200507
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 23 Jan 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGA Preservation Group | Experimental | Procedure: McKeown MIE with RGA PreservationPatients 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. |
| RGA Ligation Group | Active comparator | Procedure: McKeown MIE with RGA LigationPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| McKeown MIE with RGA PreservationPatients 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 or surgery | RGA Preservation Group |
| McKeown MIE with RGA LigationPatients 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 or surgery | RGA Ligation Group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Operative Time
Time frame: Day 1 (Day of Surgery)
Lymph Node Yield
Time frame: Day 1 (Day of Surgery)
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 23 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McKeown MIE with RGA Preservation and McKeown MIE with RGA Ligation in people with Esophageal Squamous Cell Carcinoma, run by The First Hospital of Hebei Medical University at 1 site in China.
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 4 inclusion and 6 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 23 Jan 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 China. 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 Cervical Anastomotic Leakage (time frame: Up to 30 days postoperatively). The study lists 3 primary outcomes in all. 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 23 Jan 2026.