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Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer

ConditionsProximal Gastric AdenocarcinomaGastric CancerGastroesophageal Reflux Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNanchong Central Hospital

About this trial

This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.

Eastern Cooperative Oncology Group performance status of 0 or 1.

Adequate organ function.

Disqualifiers

Patients had distant metastasis.

oesophageal invasion of more than 3 cm.

Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.

Previous chemotherapy or radiation therapy for any other malignancies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty

    Procedure/Surgery

    The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)Experimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gastroesophagus reflux disease apprised by ph monitoring

Ph monitoring by wireless or wire device

Time frame
6 months
2

Gastroesophagus reflux disease apprised by questionnaire

PGSAS-45 questionnaire is adopted.

Time frame
6 months

Secondary outcomes

1

Surgical complications of proximal gastrectomy for gastric cancer

Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.

Time frame
1 year
2

Long-term outcome

Total survival time after proximal gastrectomy for gastric cancer

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanchong Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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