NCT07363629

Brief 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. Specifically, the study compares the incidence of anastomotic leakage and stenosis between two groups of patients reconstructed with a 3cm-wide gastric conduit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

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 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    4 months postoperatively

Secondary Outcomes (2)

  • Operative Time

    Day 1 (Day of Surgery)

  • Lymph Node Yield

    Day 1 (Day of Surgery)

Study Arms (2)

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.

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.

Procedure: McKeown MIE with RGA Ligation

Interventions

McKeown MIE with RGA PreservationPROCEDURE

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.

RGA Preservation Group
McKeown MIE with RGA LigationPROCEDURE

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.

RGA Ligation Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei General Hospital

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

June 1, 2018

Primary Completion

July 31, 2020

Study Completion

November 30, 2020

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CN(1)