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Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy

U

University Medical Center Ho Chi Minh City (UMC)

Status

Not yet enrolling

Conditions

Esophageal Cancer

Treatments

Procedure: Narrow gastric tube

Study type

Interventional

Funder types

Other

Identifiers

NCT05342805
16/GCN-HDDD 2022

Details and patient eligibility

About

Currently, both the subtotal stomach and narrow gastric tube approaches are widely used for esophagogastric anastomosis after esophagectomy. Some stud- ies have concluded that the subtotal gastric conduit is superior to the wide gastric-tube approach, as it provides better protection of the submucosal vessels and can slightly increase gastric capacity.

Furthermore, blood perfusion significantly decreases after tubular gastric surgery.

Full description

Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ).

There are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate.

On the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pathologic finding by esophageal endoscopy: confirmed esophageal cancer.
  • Indication for esophagectomy
  • Age: 18 - 80 year old
  • Tumor located at the middle or lower third of the esophagus
  • ASA score: ≤ 3
  • Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion criteria

  • Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed esophageal cancer
  • Pregnant patient
  • Using colon or intesinal conduit

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Subtotal stomach
Experimental group
Description:
The vessels at the anastomosis of right and left gastric arteries were separated, then the proximal haft of lesser curvature and cardia was resected using linear staplers.
Treatment:
Procedure: Narrow gastric tube
Narrow gastric tube
Active Comparator group
Description:
At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler.
Treatment:
Procedure: Narrow gastric tube

Trial contacts and locations

1

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Central trial contact

Long D Vo, MD, PhD

Data sourced from clinicaltrials.gov

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