Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03613142
• Other study ID #: DTvsEG
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2018
• Source: Beijing Cancer Hospital
• Contact: Xin Ji, M.D.
• Phone: +86 18601201053
• Email: 18601201053[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 202
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• GastroEsophageal Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Double 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.
• Esophagogastrostomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of reflux esophagitis after operation	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.	12 months
Secondary	postoperative quality of life	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.	12months
Secondary	postoperative quality of life	Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome.	12months