Adenocarcinoma of Esophagogastric Junction, Anastomosis, Proximal Gastric Adenocarcinoma
Conditions
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
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.
Interventions
PROCEDUREarch-bridge-type esophagogastric reconstruction after proximal gastrectomy
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.
Sponsors
Peking University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical safety | From surgery day to 30 days after surgery | 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) | 1 year after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative body weight status | 1 year after surgery | Body weight loss will be recorded in outpatient. |
| Postoperative reflux esophagitis | 1 year after surgery | Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification. |
| Refinement of surgery | From surgery day to 30 days after 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 | 1 year after surgery | Laboratory tests will be done to evaluate the level of hemoglobin. |
Countries
China
Contacts
Primary ContactYinkui Wang, MD PHD
Backup ContactZiyu Li, MD PHD
Outcome results
None listed