A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

Anastomosis Clinical Trial

Official title:

A Modified "Arch-bridge-type" Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829213
• Other study ID #: 2023YJZ11
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2023
• Source: Peking University
• Contact: Yinkui Wang, MD PHD
• Phone: 0086-10-88196606
• Email: wykchangfeng[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagogastric Junction
• Anastomosis

Intervention

Procedure:
• "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy
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.

Locations

Country	Name	City	State
China	Ziyu Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From surgery day to 30 days after surgery
Primary	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.	1 year after surgery
Secondary	Postoperative body weight status	Body weight loss will be recorded in outpatient.	1 year after surgery
Secondary	Postoperative reflux esophagitis	Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification.	1 year after surgery
Secondary	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.	From surgery day to 30 days after surgery
Secondary	Postoperative hemoglobin	Laboratory tests will be done to evaluate the level of hemoglobin.	1 year after surgery