A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

NCT06300879 | Recruiting DMC

• 1 other identifier: 2023-1058
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Adenocarcinoma of Esophagogastric Junction

Keywords

proximal gastrectomy; totally laparoscopic gastrectomy; fissure technique

Outcome Measures

Primary Outcomes (5)

• Assess intraoperative Perioperative Safety by Duration of surgery.

  Time spent on the whole operation（minutes）

  intraoperative

• Assess intraoperative Perioperative Safety by Duration of anastomosis.

  Time spent on the anastomosis in minutes

  intraoperative

• Assess intraoperative Perioperative Safety by blood loss .

  Intraoperative blood loss in milliliters

  intraoperative

• 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

• 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 Outcomes (4)

• The incidence of postoperative reflux esophagitis

  3 months after surgery

• The incidence of postoperative anastomotic stenosis

  3 months after surgery

• Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30

  3 months after surgery

• Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale

  3 months after surgery

Study Arms (1)

Experimental group

EXPERIMENTAL

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Procedure: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Interventions

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique PROCEDURE

Surgical Operation: 1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. 2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. 3. Anastomosis Method: esophagogastrostomy by fissure technique. 4. 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. 5. Surgical Approach:Totally laparoscopic proximal gastrectomy.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old;
• Pathologically confirmed as adenocarcinoma;
• Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
• If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
• For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
• Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
• No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
• No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
• Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
• Preoperative ASA (American Society of Anesthesiologists) score I-III.
• Good function of important organs.
• Signed informed consent.

You may not qualify if:

• Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
• Pregnant or lactating women;
• Patients with severe mental illness;
• Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
• Severe respiratory diseases, with FEV1 \< 50% of predicted value;
• History of other malignant tumors in the past 5 years;
• Severe liver or kidney dysfunction;
• Unstable angina or myocardial infarction within the last 6 months;
• History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
• Systemic use of glucocorticoids within the last 1 month;
• Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
• Patient has participated in or is currently participating in other clinical trials (within the last 6 months).

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 8, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)