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Recruiting NCT06300879

A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

No phase Interventional Gastric Cancer Adenocarcinoma of Esophagogastric Junction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique.
Who it may be relevant to
Registry conditions: Gastric Cancer, Adenocarcinoma of Esophagogastric Junction. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Assess intraoperative Perioperative Safety by Duration of surgery. [Time frame: intraoperative]
  • Assess intraoperative Perioperative Safety by Duration of anastomosis. [Time frame: intraoperative]
  • Assess intraoperative Perioperative Safety by blood loss . [Time frame: intraoperative]
  • Postoperative recovery course [Time frame: 30 days after the surgery]
  • Postoperative TNM staging by Pathological findings . [Time frame: 30 days after the surgery]
Secondary outcome measures (4)
  • The incidence of postoperative reflux esophagitis [Time frame: 3 months after surgery]
  • The incidence of postoperative anastomotic stenosis [Time frame: 3 months after surgery]
  • Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30 [Time frame: 3 months after surgery]
  • Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale [Time frame: 3 months after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06300879 · 2023-1058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗