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NCT Number: NCT05892289

Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer

Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy.

Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Neoplasms Neoplasms by Site Peptic Ulcer Stomach Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Yang bin

CONTACT

[email protected]

13798163278

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 years ≤ age ≤ 80 years
  • The primary gastric lesions were located in the proximal third of the stomach
  • histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
  • clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
  • scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
  • The preoperative American Society of Anesthesiologists (ASA) physical status was I-III;
  • The patient's cardiopulmonary function can tolerate robotic assisted surgery;
  • The subjects have signed the informed consent form.

Exclusion criteria

  • history of upper abdominal surgery and not suitable for robotic assisted surgery
  • the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
  • with other malignant diseases or have suffered from other malignant diseases within 5 years
  • Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure
  • women are pregnant or in lactation period
  • Suffering from serious mental illness
  • history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month

Treatment and study plan

Robotic assisted proximal gastrectomy with double-flap technique

Procedure

Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.

Primary outcomes

  1. The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively

    Time frame: 12 months postoperatively

    During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification.

Secondary outcomes

  1. Quality of Life after Surgery

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively

    Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) 30-item core QoL (QLQ-C30 ver.3.0). Higher scores mean a worse outcome.

  2. Gastrointestinal Symptoms after Surgery

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively

    gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome.

  3. Changes in total protein at Follow-up

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    blood total protein(g/L) levels

  4. Changes in serum albumin at Follow-up

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    blood serum albumin(g/L) levels

  5. Changes in prealbumin at Follow-up

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    blood prealbumin(g/L) levels

  6. Changes in hemoglobin at Follow-up

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    blood hemoglobin(g/L) levels

  7. Changes in Vitamin B12 at Follow-up

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    blood Vitamin B12(μg/ml) levels

  8. Late Postoperative Morbidity

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.

  9. Early Postoperative Morbidity

    Time frame: From surgery to discharge, up to 30 days

    operation wound with seroma, hematoma, infection, dehiscence, or evisceration, anastomotic leakage, anastomotic bleeding, abdominal bleeding, abdominal abscess, intestinal obstruction morbidity, gastrointestinal bleeding, gastroparesis, postoperative pancreatitis, pancreatic fistula, chylous leakage, lung morbidity, cerebrovascular morbidity, cardiovascular morbidity, deep vein thrombosis, cholecystitis, liver dysfunction, kidney dysfunction. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.

  10. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    time to pass gas(hours)

  11. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    time to oral intake(hours)

  12. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    time to indwell gastric tube(hours)

  13. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    length of postoperative hospitalisation(days)

  14. Surgical Characteristics

    Time frame: 24 hours postoperatively

    operative time(minutes)

  15. Surgical Characteristics

    Time frame: 24 hours postoperatively

    time for reconstruction the digestive tract(minutes) during surgery

  16. Surgical Characteristics

    Time frame: 24 hours postoperatively

    blood loss during surgery(ml)

  17. Quality of Life postoperatively

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively

    Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) gastric cancer module (QLQ-STO22) questionnaire. Higher scores mean a worse outcome.

  18. Pathological Characteristics

    Time frame: 1 week postoperatively

    R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.

  19. Pathological Characteristics

    Time frame: 1 week postoperatively

    lymph nodes dissection extent for each patient in the surgery

  20. Pathological Characteristics

    Time frame: 1 week postoperatively

    number of dissected lymph nodes for each patient in the surgery

  21. body mass index postoperatively

    Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

    body mass index(kg/m^2)

  22. pain assessment postoperatively

    Time frame: Day 1 postoperatively

    We measured the pain score using visual analog scale(VAS) at 24 h after the surgery is completed. Higher scores mean a worse outcome.

  23. Proportion of participants die after surgery

    Time frame: From surgery to discharge, up to 30 days

    mortality rate

  24. Proportion of participants need to rehospitalized after surgery

    Time frame: From surgery to discharge, up to 30 days

    rehospitalization rate

Study contacts

Contact information is provided by the study sponsor or research team.

Yang bin, associate professor

CONTACT

[email protected]

13798163278

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Kunming Medical University
  • First Hospital of China Medical University
  • Gansu Provincial Hospital
  • LanZhou University
  • Liaoning Cancer Hospital & Institute
  • Qilu Hospital of Shandong University
  • Qinghai Province Fifth People's Hospital
  • Shandong Provincial Hospital
  • Sichuan Cancer Hospital and Research Institute
  • Sichuan Provincial People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Tianjin Medical University Cancer Institute and Hospital
  • Zunyi Medical College

Registry information

Official study title

Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer: a Phase II, Multi-center, Single-arm Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2023
Registry last updated
May 25, 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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