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The Safety and Efficacy of Endosdopic Intraperitoneal Subserosal Dissection for Gastric Submucosal Tumors with Extraluminal Growth Pattern

The Safety and Efficacy of Endosdopic Intraperitoneal Subserosal Dissection for Gastric Submucosal Tumors with Extraluminal Growth Pattern: a One-Arm Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067022
Enrollment
Unknown
Registered
2022-12-23
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Gastric submucosal tumor

Interventions

EISD:Endoscopic intraperitoneal subserosal dissection

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, body condition score ECOG 0-1; 2. Gastroscopy, abdominal and pelvic enhanced CT, endoscopic ultrasound and other imaging examinations confirmed that the tumor was a submucosal tumor with a diameter of less than 5cm, which grew subserosal (extraluminal growth type) in the free stomach wall of the abdominal cavity; 3. No major organ dysfunction, blood routine, lung, liver, kidney and heart functions are basically normal, laboratory indicators must meet the following requirements: blood: white blood cells > 4.0 x 10^9/L, neutrophil > 50 ~ 70%, platelet count > 100 x 10^9/L, hemoglobin > 95 g/L. Liver function: serum bilirubin was less than 1.5 times of the maximum normal value; ALT and AST were 1.5 times lower than the maximum normal value. Lung function: FEV1 >= 1.2L, FEV1% >= 50% and DLCO >= 50%; 4. Can understand the situation of this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastases (such as liver or abdominal implant) found in preoperative examination; 2. Complicated adhesions in abdominal cavity with a history of upper abdominal surgery; 3. Patients who need preoperative medication due to other diseases and affect the stability of their respiratory circulation; 4. Pregnancy, lactation or childbearing; 5. With heart, lung, liver, or kidney insufficiency; 6. Suffering from a history of uncontrollable mental illness.

Design outcomes

Primary

MeasureTime frame
Success rate of operation;En-bloc resection rate;

Secondary

MeasureTime frame
Quality-of-life;

Countries

China

Contacts

Public ContactJianwei Hu

Zhongshan Hospital, Fudan University

hu.jianwei@zs-hospital.sh.cn+86 139 1621 9299

Outcome results

None listed

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