Clinical Trial of Reconstruction After Proximal Gastrectomy

Comparing the Efficacy of Double-flap Technique Versus Single-flap Technique After Proximal Gastrectomy: a Multicentre Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Esophagitis, Reflux
• Intervention / Treatment: Procedure: left-opening single-flap technique; Procedure: double-flap group technique

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaohua Li, MD; Phone Number: +8613474299901; Email: xjyylixiaohua@163.com
• Study Contact Backup: Name: Gang Ji, MD; Phone Number: +8613572152581; Email: xijingweichang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Patients aged 18-80 years, regardless of gender;
2. Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or adenocarcinoma of the upper part of the stomach： Stage Ⅰ(cT1-2N0M0), Stage II( cT1-2N1-3M0 / cT3-4N0M0), Stage III(cT3-4aN1-3M0); patients who are suitable for surgery according to the 8th AJCC clinical staging of gastric cancer;
3. Primary lesion diagnosed by preoperative endoscopic end pathology: tumor diameter <4 cm and located in the upper part of the stomach (including the esophagogastric junction), histologically confirmed adenocarcinoma;
4. Preoperative ASA score: I, II, or III;
5. Preoperative Karnofsky physical status score: ≥ 70%; or preoperative ECOG physical status score: ≤ 2;
6. No distant metastases (confirmed by preoperative chest X-ray, abdominal ultrasound, and upper abdominal CT); no peritoneal implant metastases (confirmed by laparoscopic exploration surgery);
7. R0 surgical outcome is expected to be obtained with radical gastrectomy of D2 proximal gastric cancer;
8. Patients and their families voluntarily participate in this study and sign the informed consent form after understanding the study content.

Exclusion Criteria

1. Patients received any preoperative treatment, such as chemotherapy, radiotherapy, targeted therapy or immunotherapy; preoperative neoadjuvant chemotherapy recipients;
2. Patients with clinical stage exceeding Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or more than adenocarcinoma of the upper part of the stomach: Stage Ⅰ(cT1-2N0M0), Stage II(cT1-2N1-3M0/cT3-4N0M0), Stage III(cT3-4aN1-3M0);
3. Patients with acute infections, especially biliary tract infections;
4. Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
5. Patients with uncorrectable coagulation dysfunction;
6. Patients with vital organ failure, such as heart, lung, liver, brain, kidney, etc.
7. Severe central nervous system disease, mental disorders, or impaired consciousness;
8. Pregnant or lactating women;
9. Patients with distant metastases;
10. Patients with a primary tumor at another site diagnosed within the past 5 years;
11. Preoperative ASA score: ≥ IV;
12. Preoperative ECOG physical status score: ≥ 2;
13. History of continuous systemic corticosteroid therapy within the past 1 month;
14. History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
15. Patients with concurrent surgical treatment of other diseases;
16. Patients with immunodeficiency, immunosuppression, or autoimmune diseases (organ transplant requiring immunosuppressive therapy within the past 5 years, allogeneic bone marrow transplant patients, taking immunosuppressive drugs, etc.);
17. Patients with concurrent participation in other clinical studies;
18. Patients refusing to sign an informed consent form to participate in this study;
19. Preoperative imaging: regional fusion of enlarged lymph nodes (maximal diameter > 3 cm).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the trial group (left-opening single-flap group); left-opening single-flap group	Procedure: left-opening single-flap technique; left-opening single-flap technique
Active Comparator: the control group (double-flap group); double-flap group	Procedure: double-flap group technique; double-flap group technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of reflux esophagitis	Incidence of reflux esophagitis	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall postoperative complication rate	Overall postoperative complication rate	30 days
Incidence of anastomotic fistula	Incidence of anastomotic fistula	30 days
Operation time	Operation time	intraoperative
Bleeding loss volume	Bleeding loss volume	intraoperative
incidence of anastomotic stricture	incidence of anastomotic stricture	30 days
Incidence of reflux esophagitis	Incidence of reflux esophagitis	6 days

Collaborators and Investigators

• Sponsor: Oncogastroenterology Committee of Chinese
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Henan Provincial People's Hospital; Tang-Du Hospital; General Hospital of Ningxia Medical University; The First Affiliated Hospital of Shanxi Medical University
• Investigators: Study Chair: Nan Wang, MD, Tang-Du Hospital; Study Chair: Chao Zhang, MD, Henan Provincial People's Hospital; Study Chair: Lei Wang, MD, General Hospital of Ningxia Medical University; Study Chair: Renwei Chang, MD, The First Affiliated Hospital of Shanxi Medical University; Study Chair: Junjun She, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2027

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: left open single-flap technique, proximal gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Esophagitis, Peptic; Esophagitis
• Other Study ID Numbers: single-flap technique

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No