A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

NCT ID: NCT05829213

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Proximal Gastric Adenocarcinoma Adenocarcinoma of Esophagogastric Junction Anastomosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"arch-bridge-type" reconstruction arm

In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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"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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Ziyu Li, MD

Dr. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziyu Li, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Ziyu Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yinkui Wang, MD PHD

Role: CONTACT

0086-10-88196606

Ziyu Li, MD PHD

Role: CONTACT

0086-10-88196605

Facility Contacts

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Ziyu Li, MD PHD

Role: primary

0086-10-88196605

Yinkui Wang, MD PHD

Role: backup

0086-10-88196606

Other Identifiers

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2023YJZ11

Identifier Type: -

Identifier Source: org_study_id

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