A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
Primary Purpose
Proximal Gastric Adenocarcinoma, Adenocarcinoma of Esophagogastric Junction, Anastomosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
"arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Gastric Adenocarcinoma
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
Sites / Locations
- Ziyu LiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
"arch-bridge-type" reconstruction arm
Arm Description
In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.
Outcomes
Primary Outcome Measures
Surgical safety
The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc.
Postoperative long-term quality of life (QoL)
The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45.
Secondary Outcome Measures
Postoperative body weight status
Body weight loss will be recorded in outpatient.
Postoperative reflux esophagitis
Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification.
Refinement of surgery
During the operation, the whole process of the operation will be videotaped by laparoscopy, and after the operation, the change of the technical process of the operation was judged by comparing the operation in the video and the scheduled operation steps before the operation. In case of technical changes, the surgical team will communicate and discuss with the chief surgeon, and decide whether to adjust and optimize the surgical technique based on the postoperative situation of the patient, so as to form new technical details. Objective metrics include the total operative time, the time of esophagogastric anastomosis, the time of creating the" arch-bridge", intraoperative blood loss, the number of retrieved lymph nodes will be collected.
Postoperative hemoglobin
Laboratory tests will be done to evaluate the level of hemoglobin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05829213
Brief Title
A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
Official Title
A Modified "Arch-bridge-type" Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines.
Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Gastric Adenocarcinoma, Adenocarcinoma of Esophagogastric Junction, Anastomosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"arch-bridge-type" reconstruction arm
Arm Type
Experimental
Arm Description
In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.
Intervention Type
Procedure
Intervention Name(s)
"arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy
Intervention Description
The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines
Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.
Creating the seromuscular flap ("arch-bridge")
The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.
Primary Outcome Measure Information:
Title
Surgical safety
Description
The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc.
Time Frame
From surgery day to 30 days after surgery
Title
Postoperative long-term quality of life (QoL)
Description
The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45.
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Postoperative body weight status
Description
Body weight loss will be recorded in outpatient.
Time Frame
1 year after surgery
Title
Postoperative reflux esophagitis
Description
Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification.
Time Frame
1 year after surgery
Title
Refinement of surgery
Description
During the operation, the whole process of the operation will be videotaped by laparoscopy, and after the operation, the change of the technical process of the operation was judged by comparing the operation in the video and the scheduled operation steps before the operation. In case of technical changes, the surgical team will communicate and discuss with the chief surgeon, and decide whether to adjust and optimize the surgical technique based on the postoperative situation of the patient, so as to form new technical details. Objective metrics include the total operative time, the time of esophagogastric anastomosis, the time of creating the" arch-bridge", intraoperative blood loss, the number of retrieved lymph nodes will be collected.
Time Frame
From surgery day to 30 days after surgery
Title
Postoperative hemoglobin
Description
Laboratory tests will be done to evaluate the level of hemoglobin.
Time Frame
1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yinkui Wang, MD PHD
Phone
0086-10-88196606
Email
wykchangfeng@pku.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ziyu Li, MD PHD
Phone
0086-10-88196605
Email
ziyu_li@hsc.pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziyu Li, MD PHD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziyu Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziyu Li, MD PHD
Phone
0086-10-88196605
Email
ziyu_li@hsc.pku.edu.cn
First Name & Middle Initial & Last Name & Degree
Yinkui Wang, MD PHD
Phone
0086-10-88196606
Email
wykchangfeng@pku.edu.cn
First Name & Middle Initial & Last Name & Degree
Ziyu Li, M.D.
First Name & Middle Initial & Last Name & Degree
Fei Shan, M.D.
First Name & Middle Initial & Last Name & Degree
Yinkui Wang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
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