Clinical trial NCT06300879: A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Adenocarcinoma of Esophagogastric Junction
Keywords: proximal gastrectomy
totally laparoscopic gastrectomy
fissure technique
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Assess intraoperative Perioperative Safety by Duration of surgery.
timeFrame: intraoperative
measure: Assess intraoperative Perioperative Safety by Duration of anastomosis.
timeFrame: intraoperative
measure: Assess intraoperative Perioperative Safety by blood loss .
timeFrame: intraoperative
measure: Postoperative recovery course
timeFrame: 30 days after the surgery
measure: Postoperative TNM staging by Pathological findings .
timeFrame: 30 days after the surgery
Secondary outcomes:
measure: The incidence of postoperative reflux esophagitis
timeFrame: 3 months after surgery
measure: The incidence of postoperative anastomotic stenosis
timeFrame: 3 months after surgery
measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30
timeFrame: 3 months after surgery
measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
References: