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NCT Number: NCT06300879

A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Hankun Hao, doctor

CONTACT

[email protected]

+86 18121186328

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Procedure

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.

Primary outcomes

  1. Assess intraoperative Perioperative Safety by Duration of surgery.

    Time frame: intraoperative

    Time spent on the whole operation(minutes)

  2. Assess intraoperative Perioperative Safety by Duration of anastomosis.

    Time frame: intraoperative

    Time spent on the anastomosis in minutes

  3. Assess intraoperative Perioperative Safety by blood loss .

    Time frame: intraoperative

    Intraoperative blood loss in milliliters

  4. Postoperative recovery course

    Time frame: 30 days after the surgery

    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.

  5. Postoperative TNM staging by Pathological findings .

    Time frame: 30 days after the surgery

    AJCC(American Joint Committee on Cancer)-8th TNM staging system will be used to obtain pathology of tumor .

Secondary outcomes

  1. The incidence of postoperative reflux esophagitis

    Time frame: 3 months after surgery

    Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination

  2. The incidence of postoperative anastomotic stenosis

    Time frame: 3 months after surgery

    Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination

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

    Time frame: 3 months after surgery

    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.

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

    Time frame: 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 8, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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