Clinical Trial of Reconstruction After Proximal Gastrectomy

NCT ID: NCT05418920

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2027-07-31

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.

Conditions

Esophagitis, Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the trial group (left-opening single-flap group)

left-opening single-flap group

Group Type: EXPERIMENTAL

left-opening single-flap technique

Intervention Type: PROCEDURE

left-opening single-flap technique

the control group (double-flap group)

double-flap group

Group Type: ACTIVE_COMPARATOR

double-flap group technique

Intervention Type: PROCEDURE

double-flap group technique

Interventions

left-opening single-flap technique

left-opening single-flap technique

Intervention Type: PROCEDURE

double-flap group technique

double-flap group technique

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

Oncogastroenterology Committee of Chinese

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nan Wang, MD

Role: STUDY_CHAIR

Tang-Du Hospital

Chao Zhang, MD

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Lei Wang, MD

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Renwei Chang, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of Shanxi Medical University

Junjun She, MD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Central Contacts

Xiaohua Li, MD

Role: CONTACT

xjyylixiaohua@163.com

+8613474299901

Gang Ji, MD

Role: CONTACT

xijingweichang@163.com

+8613572152581

References

Yang QC, Wang WD, Mo ZC, Yue C, Zhou HK, Gao RQ, Yu J, Dong DH, Liu JQ, Wei JP, Yang XS, Ji G, Li XH. Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial. Front Oncol. 2022 Nov 17;12:973810. doi: 10.3389/fonc.2022.973810. eCollection 2022.

Reference Type: DERIVED

PMID: 36465382 (View on PubMed)

Other Identifiers

single-flap technique

Identifier Type: -

Identifier Source: org_study_id