Clinical trial NCT05892289: Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Robotic Surgical Procedures
minimally invasive surgical procedures
stomach neoplasm
Gastrectomy
Reflux Esophagitis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Guangxi Medical University
name: First Affiliated Hospital of Kunming Medical University
name: First Hospital of China Medical University
name: Gansu Provincial Hospital
name: Qilu Hospital of Shandong University
name: Shandong Provincial Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Sichuan Provincial People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: LanZhou University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Tianjin Medical University Cancer Institute and Hospital
name: Zunyi Medical College
name: Liaoning Cancer Hospital & Institute
name: Qinghai Province Cancer Hospital
First posted: 2023-06-07
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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..


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

Primary outcomes:
measure: The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Quality of Life after Surgery
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
measure: Gastrointestinal Symptoms after Surgery
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
measure: Changes in total protein at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in serum albumin at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in prealbumin at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in hemoglobin at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in Vitamin B12 at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Late Postoperative Morbidity
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Early Postoperative Morbidity
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Surgical Characteristics
timeFrame: 24 hours postoperatively
measure: Surgical Characteristics
timeFrame: 24 hours postoperatively
measure: Surgical Characteristics
timeFrame: 24 hours postoperatively
measure: Quality of Life postoperatively
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
measure: Pathological Characteristics
timeFrame: 1 week postoperatively
measure: Pathological Characteristics
timeFrame: 1 week postoperatively
measure: Pathological Characteristics
timeFrame: 1 week postoperatively
measure: body mass index postoperatively
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: pain assessment postoperatively
timeFrame: Day 1 postoperatively
measure: Proportion of participants die after surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Proportion of participants need to rehospitalized after surgery
timeFrame: From surgery to discharge, up to 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: