Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03613142

Enrollment

202

Registered

2018-08-02

Start date

2019-01-01

Completion date

2021-12-30

Last updated

2018-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, GastroEsophageal Cancer

Keywords

Double tract, Esophagogastrostomy, Gastric cancer, GastroEsophageal Cancer

Brief summary

The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.

Interventions

PROCEDUREDouble tract anatomosis

After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.

PROCEDUREEsophagogastrostomy

After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients diagnosed as gastric or esophagogastric adenocarcinoma 2. Age ranges from 18 to 80 3. Karnofsky assessment no less than 70 4. Completion of abdominal CT scan and ultrasound endoscopy 5. Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm) 6. radical proximal gastrectomy 7. Normal blood routine examination and biochemical test

Exclusion criteria

1. Patients need to undergo total gastrectomy or distal gastrectomy 2. Female patients with pregnancy 3. Not suitable for operation 4. Patients have already joined other clinical trials

Design outcomes

Primary

Measure	Time frame	Description
Rate of reflux esophagitis after operation	12 months	The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.

Secondary

Measure	Time frame	Description
postoperative quality of life	12months	Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome.

Contacts

Primary ContactXin Ji, M.D.

18601201053@126.com+86 18601201053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026