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Randomized prospective clinical trial of classical Whipple resection versus pancreaticoduodenectomy with retroperitoneal nerve dissection

Randomized prospective clinical trial of classical Whipple resection versus pancreaticoduodenectomy with retroperitoneal nerve dissection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002548
Enrollment
Unknown
Registered
2012-09-29
Start date
2012-08-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

pancreatic cancer

Interventions

Control Group:Whipple resection
Experimental Group:Whipple resection with retroperitoneal nerve dissection

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Perioperative confirmed pancreatic cancer by 1. CT; 2. MRI/MRCP; 3. Ultrasound/ultrasonography; 4. Endoscopic ultrasonography; 5. Endoscopic retrograde cholangiopancreatography; 6. PET-CT; 7. Biospy; 2. Aged 18-70; 3. Stage I or II; (1) IA (2) IB (3) ?A (4) ?B (5) Port vein was involved, which can be reconstructed 4. Performance status: KPS>=70; 5. Vascular involvement: Loyer stage: AD; 6. No operation contraindication; 7. No distal metastasis or ascites; 8. Tumor have not invaded adjacent artery; 9. Written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Stage III or IV; 2. Benign lesion or pancreatic body/tail malignancy; 3. Image examination found distal metastasis or ascites; 4. With mental disease; 5. Impaired viscera function (cardiac function 3~4, ALT and/or AST exceed 3 times of the upper limit, Cr beyond the upper limit); 6. Complicated with other kind of malignancy; 7. Be or plan to be pregnant, or in lactation period; 8. Attended other clinical trials three months before.

Design outcomes

Primary

MeasureTime frame
Oveal Survival;

Secondary

MeasureTime frame
Progression-free Survival;Mortality;Morbidity;State of Health;Pain;

Countries

China

Contacts

Public ContactChen Rufu
chenrf63@163.com+86 18922182828

Outcome results

None listed

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