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Study on the Safety and Efficacy of Partitioning Gastrojejunostomy with ''Highly Selective Vagolomy'' in the Treatment of Benign Pyloric and Duodenal Obstruction: A Prospective Single-Arm Clinical Study

Study on the Safety and Efficacy of Partitioning Gastrojejunostomy with ''Highly Selective Vagolomy'' in the Treatment of Benign Pyloric and Duodenal Obstruction: A Prospective Single-Arm Clinical Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052197
Enrollment
Unknown
Registered
2021-10-22
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Benign pyloric and duodenal obstruction

Interventions

Experimental group:partitioning gastrojejunostomy with "highly selective vagolomy"

Sponsors

Beijing Friendship Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient was diagnosed with benign pyloric and duodenal obstruction by gastroscopy, histopathological biopsy, abdominal plain CT, and upper gastrointestinal angiography; 2. Aged 18 to 80 years(including 18 and 80 years old); 3. Physical strength score: ECOG=70g/L; GR>=1.5x10^9/L; ALT and AST=75x10^9 /L; ALB>=30g/L, etc.); 6. Be able to understand and abide by the research protocol, agree and sign the informed consent; 7. Case data and follow-up data are relatively complete.

Exclusion criteria

Exclusion criteria: 1. Gastroscopy is contraindicated; 2. Patients who cannot tolerate anesthesia or surgery or refuse surgery; 3. Patients with coagulation dysfunction, cardiopulmonary insufficiency and other surgical contraindications, or those with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, or those who require immunosuppressive therapy for organ transplantation; 4. Pathological diagnosis of malignant pyloric and duodenal obstruction; 5. During pregnancy and lactation, those who may not take effective contraceptive measures during pregnancy and those who are planning to conceive; 6. Patients with a history of digestive system tumors or abdominal surgery; 7. Participate in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
the incidence of delayed gastric emptying within 30 days after surgery;

Secondary

MeasureTime frame
Complications within 30 days after surgery;Operation information (operation time, intraoperative blood loss);Postoperative gastrointestinal function recovery time;Recurrence rate after 3 years;Serum gastrin level;Pepsinogen levels;Gastric acid determination;13C breath test;Quality of life score;Drainage;Postoperative hospital stay;Hospital costs;Mortality within 30 days after surgery;

Countries

China

Contacts

Public ContactZhang Jun

Beijing Friendship Hospital Affiliated to Capital Medical University

zhangjun5986@ccmu.edu.cn+86 13811055986

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026