Laparoscopy, Pancreatic Cancer, Surgery
Conditions
Brief summary
Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.
Interventions
PROCEDURELaparoscopic distal pancreatectomy
Laparoscopic distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
PROCEDUREOpen distal pancreatectomy
Open distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 19 years and ≤ 80 years, no gender limitation 2. Resectable body and tail pancreatic cancer (refer to NCCN 2018) 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Tumor locates at the body and tail of the pancreas without distant metastasis 5. No celiac trunk and superior mesenteric artery invasion 6. No operation contraindication, fit for laparoscopic surgery 7. The expected survival after surgery ≥ 3 months 8. Patients who are willing and able to comply with the study procedure 9. Signed informed content obtained prior to treatment
Exclusion criteria
1. Locally advanced unresectable body and tail pancreatic cancer 2. Multi-organ and vascular resection needed 3. Patients undergoing total pancreatectomy 4. Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas 5. Distant metastasis or ascites detected by imaging 6. Severe important organ function impairment (heart, liver, kidney) 7. Patients who are with other primary malignancy or haematological disorders 8. Pregnant or nursing women 9. Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy 10. Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival | 2 years | RFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | OS |
| R0 resection rate | 2 years | R0 resection rate |
| Detected lymph node number | 2 years | Detected lymph node number |
Countries
China
Contacts
Primary ContactXianjun Yu, M.D., Ph.D.
Backup ContactHe Cheng, M.D., Ph.D.
Outcome results
None listed