A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

Gastric Cancer Clinical Trial

Official title:

A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300879
• Other study ID #: 2023-1058
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III). The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 75 years old;

2. Pathologically confirmed as adenocarcinoma;

3. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);

4. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.

5. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.

6. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.

7. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).

8. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.

9. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.

10. Preoperative ASA (American Society of Anesthesiologists) score I-III.

11. Good function of important organs.

12. Signed informed consent.

Exclusion Criteria:

1. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;

2. Pregnant or lactating women;

3. Patients with severe mental illness;

4. Preoperative temperature =38°C or infectious diseases requiring systemic treatment;

5. Severe respiratory diseases, with FEV1 < 50% of predicted value;

6. History of other malignant tumors in the past 5 years;

7. Severe liver or kidney dysfunction;

8. Unstable angina or myocardial infarction within the last 6 months;

9. History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);

10. Systemic use of glucocorticoids within the last 1 month;

11. Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);

12. Patient has participated in or is currently participating in other clinical trials (within the last 6 months).

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagogastric Junction
• Esophageal Neoplasms
• Gastric Cancer

Intervention

Procedure:
• Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
Surgical Operation: Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. Anastomosis Method: esophagogastrostomy by fissure technique. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis. Surgical Approach:Totally laparoscopic proximal gastrectomy.

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess intraoperative Perioperative Safety by Duration of surgery.	Time spent on the whole operation(minutes)	intraoperative
Primary	Assess intraoperative Perioperative Safety by Duration of anastomosis.	Time spent on the anastomosis in minutes	intraoperative
Primary	Assess intraoperative Perioperative Safety by blood loss .	Intraoperative blood loss in milliliters	intraoperative
Primary	Postoperative recovery course	Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.	30 days after the surgery
Primary	Postoperative TNM staging by Pathological findings .	AJCC(American Joint Committee on Cancer)-8th TNM staging system will be used to obtain pathology of tumor .	30 days after the surgery
Secondary	The incidence of postoperative reflux esophagitis	Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination	3 months after surgery
Secondary	The incidence of postoperative anastomotic stenosis	Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination	3 months after surgery
Secondary	Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30	QLQ-C30 is a comprehensive assessment of the overall quality of life dimensions before and after surgery for patients. Higher scores represent poorer quality of life for patients after surgery.	3 months after surgery
Secondary	Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale	QLQ-STO22 is a specific assessment for postoperative situations related to anastomosis, such as swallowing and eating.Higher scores represent poorer quality of life for patients after surgery.	3 months after surgery