Clinical trial NCT05829213: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Proximal Gastric Adenocarcinoma
Adenocarcinoma of Esophagogastric Junction
Anastomosis
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Surgical safety
timeFrame: From surgery day to 30 days after surgery
measure: Postoperative long-term quality of life (QoL)
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Postoperative body weight status
timeFrame: 1 year after surgery
measure: Postoperative reflux esophagitis
timeFrame: 1 year after surgery
measure: Refinement of surgery
timeFrame: From surgery day to 30 days after surgery
measure: Postoperative hemoglobin
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ziyu Li
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziyu Li, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: