The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.

Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.

This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.

Study Overview

• Status: Not yet recruiting
• Conditions: Proximal Early Gastric Cancer
• Intervention / Treatment: Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),

Detailed Description

This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WenQing Hu, Dr.; Phone Number: 03552066898; Email: beibeihejiyy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 20 and 80 years, regardless of gender;
2. Patients diagnosed with gastric cancer through tissue biopsy;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. American Society of Anesthesiologists (ASA) classification of I to III;

5. Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:

   Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);

6. Voluntary signing of informed consent.

Exclusion Criteria:

1. Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
2. Presence of contraindications to surgery;
3. Multiple malignant lesions in the stomach;
4. Presence of other malignancies that may affect the preservation of stomach function;
5. Previous upper abdominal surgery (excluding cholecystectomy);
6. Preoperative examination reveals active peptic ulcer;
7. Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
8. Pregnant or breastfeeding women;
9. Conditions deemed unsuitable for participation in this study by the investigator.

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: double-flap technique（DFT）; Laparoscopic proximal gastrectomy with double flap anastomosis group	Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),; DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.
Active Comparator: double-tract reconstruction（DTR）; Laparoscopic proximal gastrectomy with double-tract anastomosis group	Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),; DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with reflux esophagitis	The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.	Within 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.	Within 12 months after surgery
Operation time	From the beginning of surgery to the end of surgery	Perioperative period
Kamikawa anastomosis time	The time of making the seromuscular flap and the time of esophagogastrostomy were included	Perioperative period
intraoperative blood loss	The operation begins to end the amount of bleeding.	Perioperative period
Weight change	Calculated in kilograms	Within 12 months after surgery
Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	Within 12 months after surgery
Albumin value	The concentration of albumin in the blood, expressed in g/L.	Within 12 months after surgery
Pre albumin value	The concentration of pre albumin in the blood, expressed in g/L.	Within 12 months after surgery
Hemoglobin value	The concentration of Hemoglobin in the blood, expressed in g/L.	Within 12 months after surgery
Folic acid value	The concentration of Folic acid value in the blood, expressed in ng/mL.	Within 12 months after surgery
Vitamin B12 value	The concentration of Vitamin B12 value in the blood, expressed in uug/L.	Within 12 months after surgery
Ferritin value	The concentration of Vitamin B12 value in the blood, expressed in ug/L.	Within 12 months after surgery
Nutritional risk screening 2002	The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status.	Within 12 months after surgery

Collaborators and Investigators

• Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College
• Investigators: Study Chair: WenQing Hu, 502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CZPH-0001

Drug and device information, study documents

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