To hear about similar clinical trials, please enter your email below
Trial Title:
Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer
NCT ID:
NCT05892289
Condition:
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Robotic Surgical Procedures
minimally invasive surgical procedures
stomach neoplasm
Gastrectomy
Reflux Esophagitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic assisted proximal gastrectomy with double-flap technique
Description:
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.
Arm group label:
Robotic assisted proximal gastrectomy with double-flap technique
Summary:
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..
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 20 years ≤ age ≤ 80 years
2. The primary gastric lesions were located in the proximal third of the stomach
3. histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
4. 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)
5. 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).).
6. The preoperative American Society of Anesthesiologists (ASA) physical status was
I-III;
7. The patient's cardiopulmonary function can tolerate robotic assisted surgery;
8. The subjects have signed the informed consent form.
Exclusion Criteria:
1. history of upper abdominal surgery and not suitable for robotic assisted surgery
2. the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
3. with other malignant diseases or have suffered from other malignant diseases within
5 years
4. Excessive tension for esophagogastric anastomosis and require changing the
reconstruction procedure
5. women are pregnant or in lactation period
6. Suffering from serious mental illness
7. history of continuous systemic corticosteroid or immunosuppressive drug treatment
within 1 month
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Yang bin
Phone:
13798163278
Email:
yyzsu@163.com
Start date:
June 10, 2023
Completion date:
December 10, 2026
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Kunming Medical University
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Gansu Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Sichuan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
LanZhou University
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Zunyi Medical College
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Qinghai Province Cancer Hospital
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05892289
