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Trial Title:
A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
NCT ID:
NCT05829213
Condition:
Proximal Gastric Adenocarcinoma
Adenocarcinoma of Esophagogastric Junction
Anastomosis
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
"arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy
Description:
1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment
Guidelines
2. Transection of the esophagus is performed using a linear stapler 2cm away from the
proximal end of the tumor.
3. Creating the seromuscular flap ("arch-bridge")
4. The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum
is re-established to perform the intracorporeal anastomosis.
Arm group label:
"arch-bridge-type" reconstruction arm
Summary:
The double-flap technique (DFT) is an effective digestive tract reconstruction method
after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux
esophagitis. But its clinical application is restricted due to the technical complexity.
Our surgical team devise a modified esophagogastric reconstructive method which we term
the "arch-bridge-type" reconstruction based on the principle of DFT. The aim of this
single-arm prospective study is to assess the safety and feasibility of the
"arch-bridge-type" reconstruction after PG.
Detailed description:
1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment
Guidelines.
2. Transection of the esophagus is performed using a linear stapler 2cm away from the
proximal end of the tumor.
3. Creating the seromuscular flap ("arch-bridge"):
(1) The stomach is resected by a linear stapling device. (2) A "匚" shaped
seromuscularflap (3.0cm×4.0cm) is created utilizing electrocautery extracorporeally by
dissecting submocosal and muscular layer of the anterior wall of the remnant stomach.
(3) The opening of the flap is interrupted sutured by 4-0 absorbable suture, then the
"arch-bridge" is created.
4.The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is
re-established to perform the intracorporeal anastomosis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric
junction
- diameter of the tumor less than 4cm
- ECOG performance status score ≤2
- no distant metastasis
- informed consent is signed
Exclusion Criteria:
- metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction
- remnant gastric cancer
- patient requires emergency surgery
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ziyu Li
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Ziyu Li, MD PHD
Phone:
0086-10-88196605
Email:
ziyu_li@hsc.pku.edu.cn
Contact backup:
Last name:
Yinkui Wang, MD PHD
Phone:
0086-10-88196606
Email:
wykchangfeng@pku.edu.cn
Investigator:
Last name:
Ziyu Li, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Fei Shan, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yinkui Wang, M.D.
Email:
Sub-Investigator
Start date:
November 1, 2021
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05829213
