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A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.

T

Tang-Du Hospital

Status

Invitation-only

Conditions

Proximal Gastrectomy
Gastroesophageal-junction Cancer
Gastroesophagostomy

Treatments

Procedure: PTST(parachute-tunnel-style technique)for esophagogastrostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06217991
XKT-Y-20221148

Details and patient eligibility

About

  1. To evaluate the safety, simplicity and effectiveness of the gastric function (anti-reflux) preservation of the innovative "parachute-tunnel-style technique" (PTST) in laparoscopic proximal gastrectomy.
  2. To investigate the correlation between anastomotic stenosis and blood supply of serosa-muscle flap,suture after esophagogastric anastomosis.(obtain objective indexes such as blood supply, healing pattern and length change of serosa-muscle flap through animal experiments)

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gastric cancer was confirmed histopathologically;
  • Patients who may undergo proximal gastrectomy according to guidelines;
  • Early upper gastric cancer, more than 1/2 of the distal gastric remnant remained after resection;
  • Esophagogastric junction carcinoma with maximum diameter ≤4 cm;
  • Patients with advanced upper gastric cancer (MSI-H) achieved cCR by neoadjuvant immunochemotherapy.

Exclusion criteria

  • Patients with systemic conditions that cannot tolerate laparoscopic surgery;
  • Distal gastric remnant was less than 1/2 after proximal gastrectomy.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

PTST anastomose group after proximal gastrectomy
Experimental group
Description:
Standard procedure: Patient placed in a supine position and proximal gastrectomy performed under general anesthesia. 1. Lymph node dissection 2. Cut the esophagus 3. Gymnosis of gastric curvature greater and gastric curvature lesser 4. The specimen removed from the stomach(5cm away) 5. Preparation of serosa-muscle flap: Mark two straight lines, A and B, about 3cm long, with methylene blue on the anterior wall of the stomach about 2cm and 6cm from the gastric stump. The electrocoagulation and cutting power of the electrotome were adjusted to 10 watts, and the serosa-muscle layer of the gastric wall was cut along the marked line with the electrotome. With the help of the assistant, the surgeon separated the gastric parietal serosa-muscle layer from the submucosa along line B to line A. When the dissociation reached the middle point of the tunnel, it should be dissociated along line A to line B, completely dissociated the gastric parietal serosa-muscle layer from the submucosa.
Treatment:
Procedure: PTST(parachute-tunnel-style technique)for esophagogastrostomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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