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Anti-reflux effect of modified tubular gastroesophageal anastomosis with proximal gastrectomy for proximal gastric cancer: A Prospective Single-Arm Trial

Anti-reflux effect of modified tubular gastroesophageal anastomosis with proximal gastrectomy for proximal gastric cancer: A Prospective Single-Arm Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071337
Enrollment
Unknown
Registered
2023-05-11
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Caner

Interventions

Group interventon:laparoscopic proximal gastrectomy with Overlap anastomosis plus Toupet

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)Patients with clear pathological diagnosis and clinical evaluation of T1 or T2-3 stage (tumor = 4cm) located in the upper one-third of the stomach with proximal gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma type II/III), without lymph node metastasis or distal perigastric lymph node metastasis (4d, 5, and 6 groups) on imaging (CT/EUS, etc.); (2)Male or female patients aged 18-75 years old; (3)No previous history of concomitant malignant tumors; (4)The heart, lung, liver, and kidney functions are basically normal, with an ECOG physical condition score of 0-1; (5)Follow up for at least 5 years after surgery or until patient death; (6) The patient's informed consent form has been signed.

Exclusion criteria

Exclusion criteria: (1)Gastric stump cancer; (2) Postoperative pathology confirmed T4 or IV stage (16LN metastasis or positive peritoneal exfoliated cells); (3) Borrmann III (tumor diameter greater than 8cm) or IV type, or tumor invasion of the middle one-third of the stomach; (4) The number of lymph node dissection is less than 16; (5) Receiving neoadjuvant chemotherapy; (6) Multiple gastric cancer (= 2 lesions); (7) Patients with R1 resection confirmed by postoperative pathology; (8) Pregnant or lactating women; (9) Emergency surgery; (10) Distant metastasis of liver, lung, bone, etc; Or supraclavicular lymph nodes, pelvic floor or ovarian species, peritoneal dissemination, etc; (11) Patients with other serious diseases, including cardiovascular, respiratory, kidney or liver diseases, hypertension and diabetes with poor control; (12) Mental disorders or illnesses; (13) Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment; (14) Patients who have undergone surgery and whose impact has not yet been eliminated; (15) History of gastric or esophageal malignant tumors, including stromal tumors, sarcomas, lymphoma, carcinoids, etc; (16) Poor patient compliance or researchers considering poor patient compliance; (17) Some researchers believe that patients with other clinical and laboratory conditions should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Incidences of reflux esophagitis and anastomotic stenosis 12 months after operation;

Secondary

MeasureTime frame
Nutrition indicators;Operative time;number of harvested lymph nodes;R0 resection rate;intraoperative blood loss;Unplanned readmission rate within 30 days after surgery;mobidity;motality within 30-day after operation;

Countries

China

Contacts

Public ContactYang zuli

The Sixth Affiliated Hospital, Sun Yat-sen University

yzlhlj7068@163.com+86 135 7006 9083

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026