An interventional study of "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy in Proximal Gastric Adenocarcinoma, Adenocarcinoma of Esophagogastric Junction and Anastomosis, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Peking University · Not applicable, Interventional, and Treatment
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.
(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.
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This study's planned enrollment of 30 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
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Exclusion Criteria:
In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.
Procedure: "arch-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.
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.
Time frame: From surgery day to 30 days after surgery
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.
Time frame: 1 year after surgery
Postoperative body weight status
Body weight loss will be recorded in outpatient.
Time frame: 1 year after surgery
Postoperative reflux esophagitis
Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification.
Time frame: 1 year after surgery
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.
Time frame: From surgery day to 30 days after surgery
Postoperative hemoglobin
Laboratory tests will be done to evaluate the level of hemoglobin.
Time frame: 1 year after surgery
Plan to share: No
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Peking University