Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy

Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Narrow gastric tube

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long D Vo, MD, PhD; Phone Number: +84. 918 133 915; Email: long.vd@umc.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • University Medical Center Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
Active Comparator: 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early complications (30-day complications): rate of anastomotic leakage	Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.	30 days after surgery
Early complications (30-day complications): rate of anastomotic stricture	Comparison of the rate of anastomotic stricture. All complications will be classified according to the Clavien-Dindo classification.	30 days after surgery
Early complications (30-day complications): rate of bleeding	Comparison of the rate of bleeding. All complications will be classified according to the Clavien-Dindo classification.	30 days after surgery
Early complications (30-day complications): rate of pneumonia	Comparison of the rate of pneumonia. All complications will be classified according to the Clavien-Dindo classification.	30 days after surgery
Early complications (30-day complications): rate of mortality.	Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.	30 days after surgery
Early complications (30-day complications): rate of reoperation.	Comparison of the rate of reoperation. All complications will be classified according to the Clavien-Dindo classification.	30 days after surgery
Early outcomes (30-day post operative): length of hospital stay.	Comparison of the length of hospital stay.	30 days after surgery
Early outcomes (30-day post operative): day of oral intake.	Comparison of the day of oral intake.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nutritional status: body weight	Comparison of body weight at 6, 12 months and every year after surgery	6, 12 months and 1 year after surgery
Postoperative nutritional status: serum total protein	Comparison of serum total protein at 6, 12 months and every year after surgery	6, 12 months and 1 year after surgery
Postoperative nutritional status: albumin level	Comparison of albumin level at 6, 12 months and every year after surgery	6, 12 months and 1 year after surgery
Postoperative nutritional status: hemoglobin	Comparison of hemoglobin at 6, 12 months and every year after surgery	6, 12 months and 1 year after surgery
Reflux esophagitis	Reflux esophagitis will be evaluated using the Los Angeles classification at 6, 12 months and every year after surgery	6, 12 months and 1 year after surgery
Residue Gastritis Bile	RGB (Residue Gastritis Bile) classification will be used to evaluate status of remnant stomach 6 to 12 months after surgery	6, 12 months and 1 year after
Patients' health-related quality of life	Patients' health-related quality of life will be evaluated using GSRS (Gastrointestinal Symptom Rating Scale) score at 6, 12 months and every year after surgery	6, 12 months and 1 year after
Late complications: anastomotic stricture	Comparison of the rate anastomotic stricture complications during the follow-up period	6, 12 months and 1 year after
Late complications: anastomotic ulcer	Comparison of anastomotic ulcer during the follow-up period	6, 12 months and 1 year after
Others late complications	Comparison of other late complications during the follow-up period	6, 12 months and 1 year after
Oncological outcomes: overall survival rate	Comparison of overall survival rate during the follow-up period	6, 12 months and 1 year after
Oncological outcomes: rate of death due to the cancer	Comparison of rate of death due to the cancer, and death from all causes during the follow-up period	6, 12 months and 1 year after
Oncological outcomes: recurrence, metastasis	Comparison of recurrence, metastasis during the follow-up period	6, 12 months and 1 year after

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)
• Investigators: Study Director: Long D Vo, MD, PhD, University Medical Center, HCMC, VN

Study record dates

Study Major Dates

• Study Start (Anticipated): May 3, 2022
• Primary Completion (Anticipated): April 15, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: anastomosis; subtotal stomach; narrow gastric tube
• Other Study ID Numbers: 16/GCN-HDDD 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No