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

Stomach Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05892289
• Other study ID #: SYSKY-2022-275-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: December 10, 2026

Study information

• Verified date: May 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yang bin, associate professor
• Phone: 13798163278
• Email: yyzsu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 10, 2026
• Est. primary completion date: December 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Robotic assisted proximal gastrectomy with double-flap technique
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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (16)

Lead Sponsor

Collaborator

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

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 Tumor Hospital & Institute, Qilu Hospital of Shandong University, Qinghai Province Cancer Hospital, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively	During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification.	12 months postoperatively
Secondary	Quality of Life after Surgery	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.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Secondary	Gastrointestinal Symptoms after Surgery	gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Secondary	Changes in total protein at Follow-up	blood total protein(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in serum albumin at Follow-up	blood serum albumin(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in prealbumin at Follow-up	blood prealbumin(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in hemoglobin at Follow-up	blood hemoglobin(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in Vitamin B12 at Follow-up	blood Vitamin B12(µg/ml) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Late Postoperative Morbidity	adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Early Postoperative Morbidity	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.	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	time to pass gas(hours)	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	time to oral intake(hours)	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	time to indwell gastric tube(hours)	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	length of postoperative hospitalisation(days)	From surgery to discharge, up to 30 days
Secondary	Surgical Characteristics	operative time(minutes)	24 hours postoperatively
Secondary	Surgical Characteristics	time for reconstruction the digestive tract(minutes) during surgery	24 hours postoperatively
Secondary	Surgical Characteristics	blood loss during surgery(ml)	24 hours postoperatively
Secondary	Quality of Life 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.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Secondary	Pathological Characteristics	R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.	1 week postoperatively
Secondary	Pathological Characteristics	lymph nodes dissection extent for each patient in the surgery	1 week postoperatively
Secondary	Pathological Characteristics	number of dissected lymph nodes for each patient in the surgery	1 week postoperatively
Secondary	body mass index postoperatively	body mass index(kg/m^2)	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	pain assessment 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.	Day 1 postoperatively
Secondary	Proportion of participants die after surgery	mortality rate	From surgery to discharge, up to 30 days
Secondary	Proportion of participants need to rehospitalized after surgery	rehospitalization rate	From surgery to discharge, up to 30 days