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The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?

Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01696682
Enrollment
200
Registered
2012-10-01
Start date
2012-09-30
Completion date
2014-12-31
Last updated
2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leakage

Keywords

minimally invasive esophagectomy, anastomotic leakage, gastric conduit

Brief summary

The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.

Detailed description

Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.

Interventions

PROCEDURENarrowed Gastric Conduit

The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy

PROCEDUREWidened Gastric Conduit

A widened gastric tube will be formed during the surgery

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients underwent minimally invasive esophagectomy(three-hole procedure) 2. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy

Exclusion criteria

1. With previous cancer history 2. Severe Co-morbidity

Design outcomes

Primary

MeasureTime frameDescription
The anastomotic leakage ratethe anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeksThe anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.

Countries

China

Contacts

Primary ContactYaxing Shen, MD
SHEN.YAXING@ZS-HOSPITAL.SH.CN86-13661983366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026