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Establishment of an optimized surgical procedure for improving the survival and prognosis of pancreatic body and tail cancer and evaluation of the clinical application value

A prospective randomized controlled clinical trial of radical antegrade modular pancreatic splenectomy versus standard radical pancreatic body and tail cancer resection for patients with resectable pancreatic body and tail duct adenocarcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036489
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Pancreatic Cancer

Interventions

RAMPS:To perform RAMPS
SRPS:To perform standard radical resection of pacreatosplenectomy

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old; 2. Resectable pancreatic body and tail ductal adenocarcinoma with both preoperative and intraoperative evaluation(refer to NCCN guideline 2018 of Pancreatic Cancer); 3. ECOG Performance Status 0-1; 4. Adenocarcinoma of pancreatic body and tail duct, without distant metastasis and ascites; 5. The estimated survival time is = 3 months; 6. Follow-up in time and obey the research requirements; 7. Be voluntary to this clinical trial and can sign the informed consent; 8. Normal hematological index (Leukocyte, platelet, liver function, renal function, DIC, electrolyte index, Hb >10g/dL).

Exclusion criteria

Exclusion criteria: 1. The patients with distant metastasis according to preoperative tumor staging; Patients with recurrent pancreatic ductal adenocarcinoma; 2. Recurrenced pancreatic ductal adenocarcinoma; 3. The artery or vein is involved and could not be resected or reconstructed(according to preoperative evaluation or intraoperative evaluation after exploration); 4. Patients with cardiopulmonary disfunction and cannot tolerate operation; 5. The patients accepted neoadjuvant chemotherapy and radiotherapy before operation; 6. Patients with other malignancies or hematopathy 7. Before the operation, the total bilirubin was more than 250 µmol/L without preoperative biliary drainage or after biliary drainage, the total bilirubin was still more than 250 µmol/L; 8. Pregnancy diagnosed, planned pregnancy and lactating female patients Refusal to sign consent. 9. Intraoperative exclusion include:Tumor metastasis; not pancreatic primary disease; unresectable pancreatic body/tail adenocarcinoma; 10. Postoperative exclusion include: not pancreatic ductal adenocarcinoma according to pathological examination; 11. Withdrawal of informed consent; 12. Willingness to withdraw from the study.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
disease free survival;R0 resection rate;retrieved lymph nodes;

Countries

China

Contacts

Public ContactYuanchi Weng

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

wyuanchi@126.com+86 13774209138

Outcome results

None listed

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