Clinical Trial of Reconstruction After Proximal Gastrectomy

Not Applicable

Not yet recruiting

• Conditions: Esophagitis, Reflux
• Interventions: Procedure: double-flap group technique; Procedure: left-opening single-flap technique

• Registration Number: NCT05418920
• Lead Sponsor: Oncogastroenterology Committee of Chinese

Brief Summary

1) To explore a simple, safe, post-proximal gastrectomy reconstruction method with good absorption and digestive function in order to improve patients' postoperative quality of life; 2) To fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field in China; 3) To utilize the experience and foundation of gastrointestinal surgery in the treatment of gastric cancer and integrate the advantageous resources in China; 4) To establish a large-sample, multicenter randomized clinical study in order to promote the establishment and improvement of relevant norms of gastrointestinal reconstruction

Detailed Description

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths each year. Although the incidence of gastric cancer has decreased worldwide compared to the past, the incidence of esophagogastric junction cancer and upper 1/3 gastric cancer is gradually increasing. Currently, the main treatment for esophagogastric junction cancer and upper gastric cancer is surgery. However, there is no clinical consensus on the choice of surgical approach for these patients. Compared with total gastrectomy, proximal gastrectomy can preserve the physiological function of the stomach and has great advantages in nutrient absorption, thus it has been widely accepted in Asian countries.

However, the risk of developing reflux esophagitis after proximal gastrectomy is high, which seriously affects patients' postoperative quality of life. In order to reduce the occurrence of postoperative complications, clinicians continue to improve the methods of GI reconstruction. Currently, the common methods of GI reconstruction after proximal gastrectomy include esophagogastrostomy (EG), jejunal intubation (JI), jejunal pouch intubation (JPI), and dual-tract reconstruction (DTR). However, the choice of the optimal reconstruction method after proximal gastrectomy remains controversial, and there is no standard approach to GI reconstruction. In 2016, Kuroda et al. reported a new surgical approach with a double-flap technique after proximal gastrectomy and showed satisfactory short-term outcomes compared with conventional esophagogastric anastomosis. At the 1-year postoperative follow-up, no reflux esophagitis was detected in all patients. At the same time, the rate of anastomotic stenosis was noteworthy.

This study will be the first attempt at a left-open single-flap technique, which was modified from the double-flap technique. The short-term outcome was satisfactory in all patients. This study will establish a large sample, multicenter randomized clinical study. By exploring a simple, safe, good absorption and digestive function method of post-proximal gastrectomy reconstruction to improve patients' postoperative quality of life and fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field. This will promote the establishment and improvement of the specifications related to gastrointestinal reconstruction.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-14
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05
• Study Start: 2022-08-01
• Primary Completion: 2024-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group (double-flap group)	double-flap group technique	double-flap group
the trial group (left-opening single-flap group)	left-opening single-flap technique	left-opening single-flap group

Primary Outcome Measures

Name	Time	Method
Incidence of reflux esophagitis	12 months	Incidence of reflux esophagitis

Secondary Outcome Measures

Name	Time	Method
Overall postoperative complication rate	30 days	Overall postoperative complication rate
Bleeding loss volume	intraoperative	Bleeding loss volume
incidence of anastomotic stricture	30 days	incidence of anastomotic stricture
Operation time	intraoperative	Operation time
Incidence of anastomotic fistula	30 days	Incidence of anastomotic fistula
Incidence of reflux esophagitis	6 days	Incidence of reflux esophagitis