Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy

NCT ID: NCT05342805

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2024-08-30

Brief Summary

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.

Detailed 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

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Subtotal stomach

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.

Group Type: EXPERIMENTAL

Narrow gastric tube

Intervention Type: PROCEDURE

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

Narrow gastric tube

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.

Group Type: ACTIVE_COMPARATOR

Narrow gastric tube

Intervention Type: PROCEDURE

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

Interventions

Narrow gastric tube

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Long D Vo, MD, PhD

Role: STUDY_DIRECTOR

University Medical Center, HCMC, VN

Locations

University Medical Center Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Central Contacts

Long D Vo, MD, PhD

Role: CONTACT

long.vd@umc.edu.vn

+84. 918 133 915

Other Identifiers

16/GCN-HDDD 2022

Identifier Type: -

Identifier Source: org_study_id