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A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

P

Peking University

Status

Enrolling

Conditions

Anastomosis
Proximal Gastric Adenocarcinoma
Adenocarcinoma of Esophagogastric Junction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05829213
2023YJZ11

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

"arch-bridge-type" reconstruction arm
Experimental group
Description:
In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.
Treatment:
Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy

Trial contacts and locations

1

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Central trial contact

Yinkui Wang, MD PHD; Ziyu Li, MD PHD

Data sourced from clinicaltrials.gov

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