Clinical trial NCT05342805: Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy
Official title: Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: subtotal stomach
narrow gastric tube
anastomosis
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Early complications (30-day complications): rate of anastomotic leakage
timeFrame: 30 days after surgery
measure: Early complications (30-day complications): rate of anastomotic stricture
timeFrame: 30 days after surgery
measure: Early complications (30-day complications): rate of bleeding
timeFrame: 30 days after surgery
measure: Early complications (30-day complications): rate of pneumonia
timeFrame: 30 days after surgery
measure: Early complications (30-day complications): rate of mortality.
timeFrame: 30 days after surgery
measure: Early complications (30-day complications): rate of reoperation.
timeFrame: 30 days after surgery
measure: Early outcomes (30-day post operative): length of hospital stay.
timeFrame: 30 days after surgery
measure: Early outcomes (30-day post operative): day of oral intake.
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Postoperative nutritional status: body weight
timeFrame: 6, 12 months and 1 year after surgery
measure: Postoperative nutritional status: serum total protein
timeFrame: 6, 12 months and 1 year after surgery
measure: Postoperative nutritional status: albumin level
timeFrame: 6, 12 months and 1 year after surgery
measure: Postoperative nutritional status: hemoglobin
timeFrame: 6, 12 months and 1 year after surgery
measure: Reflux esophagitis
timeFrame: 6, 12 months and 1 year after surgery
measure: Residue Gastritis Bile
timeFrame: 6, 12 months and 1 year after
measure: Patients' health-related quality of life
timeFrame: 6, 12 months and 1 year after
measure: Late complications: anastomotic stricture
timeFrame: 6, 12 months and 1 year after
measure: Late complications: anastomotic ulcer
timeFrame: 6, 12 months and 1 year after
measure: Others late complications
timeFrame: 6, 12 months and 1 year after
measure: Oncological outcomes: overall survival rate
timeFrame: 6, 12 months and 1 year after
measure: Oncological outcomes: rate of death due to the cancer
timeFrame: 6, 12 months and 1 year after
measure: Oncological outcomes: recurrence, metastasis
timeFrame: 6, 12 months and 1 year after
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
affiliation: University Medical Center, HCMC, VN
name: Long D Vo, MD, PhD
role: STUDY_DIRECTOR
References: