Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05342805
• Other study ID #: 16/GCN-HDDD 2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2022
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Long D Vo, MD, PhD
• Phone: +84. 918 133 915
• Email: long.vd[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

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

Locations

Country	Name	City	State
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Early outcomes (30-day post operative): length of hospital stay.	Comparison of the length of hospital stay.	30 days after surgery
Primary	Early outcomes (30-day post operative): day of oral intake.	Comparison of the day of oral intake.	30 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative nutritional status: hemoglobin	Comparison of hemoglobin at 6, 12 months and every year after surgery	6, 12 months and 1 year after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Late complications: anastomotic stricture	Comparison of the rate anastomotic stricture complications during the follow-up period	6, 12 months and 1 year after
Secondary	Late complications: anastomotic ulcer	Comparison of anastomotic ulcer during the follow-up period	6, 12 months and 1 year after
Secondary	Others late complications	Comparison of other late complications during the follow-up period	6, 12 months and 1 year after
Secondary	Oncological outcomes: overall survival rate	Comparison of overall survival rate during the follow-up period	6, 12 months and 1 year after
Secondary	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
Secondary	Oncological outcomes: recurrence, metastasis	Comparison of recurrence, metastasis during the follow-up period	6, 12 months and 1 year after