Trial Title:
Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer
NCT ID:
NCT05890339
Condition:
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
laparoscopy
minimally invasive surgical procedures
stomach neoplasm
Gastrectomy
Reflux Esophagitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic Proximal Gastrectomy With Double-flap Technique
Description:
Patients in this group receive laparoscopic 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 esophagogastric reconstruction.
Arm group label:
Laparoscopic Proximal Gastrectomy With Double-flap Technique
Intervention type:
Procedure
Intervention name:
Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
Description:
Patients in this group receive laparoscopic total gastrectomy with D1+/D2 lymph node
dissection(D1+ for stage IA：Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p；D2 for stage IB: Nos.1,
2, 3, 4, 5, 6, 7, 8a, 9, 11p and 11d, 12a). The Roux-en-Y esophagojejunostomy method is
used for the esophagojejunal reconstruction.
Arm group label:
Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
Summary:
Proximal early gastric cancer can choose radical total gastrectomy or proximal
gastrectomy. But if use simple esophagogastric anastomosis for proximal gastrectomy, the
incidence of postoperative reflux esophagitis is up to 62%, 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 status than total gastrectomy.
Double-flap technique is a new surgical procedure for the reconstruction between
esophagus and remnant stomach, which was started to be applied to digestive tract
reconstruction in patients with proximal early gastric cancer in 2016. It can reduce the
occurrence of reflux oesophagitis. At present, the studies for double-flap technique in
China and other countries are mostly retrospective studies, and there are short of
large-scale prospective studies and evidence of evidence-based medicine.
The applicant has initiated a phase II, single center, single arm study and the results
suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction
technique was safe and effective for treating proximal early gastric cancer. To further
validate the short and long-term outcomes of this procedure, a multicentre, open label,
prospective, superiority and randomised controlled clinical trial was set up to compare
laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total
gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer. It include
216 patients with proximal early gastric cancer. The primary outcome is the proportion of
patients who develop reflux esophagitis within 12 months after surgery. The short and
long-term oncological outcomes are also explored. This trial can provide high-grade
evidence of evidence-based medicine for double-flap technique's clinical applications .
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(AJCC) staging system(Clinical stage was
determined based on the finding of endoscopic ultrasonography and/or
thoraco-abdominal contrast-enhanced computed tomography)
5. scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or
laparoscopic total 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; The patient's cardiopulmonary function can tolerate laparoscopic surgery.
7. The patients have signed the informed consent form.
Exclusion Criteria:
1. history of upper abdominal surgery (except laparoscopic cholecystectomy);
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. require simultaneous surgery due to complicated with other diseases
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
Start date:
June 10, 2023
Completion date:
May 10, 2033
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Sichuan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Kunming Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
Zunyi Medical College
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Gansu Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Qinghai Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
LanZhou University
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/NCT05890339
