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Short and long term outcome after laparoscopic Warshaw and Kimura techniques for spleen-preserving distal pancreatectomy: A single-center patient-blinded randomized controlled trial

Short and long term outcome after laparoscopic Warshaw and Kimura techniques for spleen-preserving distal pancreatectomy: A single-center patient-blinded randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057763
Enrollment
Unknown
Registered
2022-03-16
Start date
2022-03-14
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Distal pancreatic disease

Interventions

Kimura group:Laparoscopic spleen-preserving pancreatectomy using the kimura method
Warshaw group:Laparoscopic spleen-preserving pancreatectomy using the Warshaw

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Benign or low-grade malignant diseases of the pancreatic body and tail, such as endocrine tumors of the pancreas, mucinous cystic tumors of the pancreas, serous cystic tumors of the pancreas, intraductal papillary and mucinous tumors of the pancreas, solid pseudopapillary tumors of the pancreas, pancreatic cysts, etc. 2. Aged >=18 years and <85 years. 3. The Eastern Cooperative Oncology Group performance status (ECOG PS) score should be 0 or 1. 4. American Society of Anesthesiology (ASA) grade I-III. 5. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Preoperative suspected malignancy or intraoperative frozen pathology reported malignant pancreatic body and tail disease; 2. Pregnant or lactating patients; 3. Severe mental disorder; 4. Patients with a history of abdominal surgery and unable to perform laparoscopic exploration for severe adhesion in the abdominal cavity; 5. The patient was included in other research protocols that interfered with the outcome indicators of this experiment; 6. Unstable angina pectoris, myocardial infarction or cerebrovascular accident within the past 6 months; 7. forced expiratory volume in 1 second (FEV1) was less than 50% of the predicted value; 8. Patients with cirrhosis complicated with portal hypertension were found by preoperative or intraoperative endoscopic exploration; 9. Hypersplenism; 10. Complicated diseases requiring the removal of the spleen, such as hereditary spherocytosis, idiopathic thrombocytopenic purpura, splenic tumor, etc.; 11. Suspected or evidence of congenital and acquired coagulopathy (e.g. haemophilia, severe aplasia or severe liver disease); The following medications were used: clopidogrel within 5 days before surgery or tirofiban within 2 days before surgery or if coumarin was used, INR >1.4; 12. Complicated with splenic vascular lesions, such as splenic aneurysm and thrombosis; 13. Preoperative imaging examination (CT or MR) indicated tumor invasion of splenic vessels or intraoperative exploration revealed dense adhesion of tumor and spleen; 14. Preoperative enhanced CT or intraoperative exploration revealed the presence of gastroesophageal varices or perigastric varices in the patient; 15. The maximum diameter of the tumor is greater than 6cm.

Design outcomes

Primary

MeasureTime frame
intraoperative blood loss;the incidence of gastric varices;

Secondary

MeasureTime frame
length of operation;splenic infarct;spleen volume;reoperation;post-operative pancreatic fistula;conversion to an open procedure;intraoperative transfusions;postpancretectomy hemorrhage;secondary splenectomy;postoperative hospital stay;delayed gastric emptying;postoperative surgical site infection;postoperative health score EQ-5D-5 L;new diabetes after pancreatic surgery;death rate;

Countries

China

Contacts

Public ContactCai Yunqiang
494374409@qq.com+86 17721950223

Outcome results

None listed

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