An interventional study of Laparoscopic distal pancreatectomy and Open distal pancreatectomy in Pancreatic Cancer, Surgery and Laparoscopy, sponsored by Fudan University. Status unknown at 11 sites in China. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Fudan University · Not applicable, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 306 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
Procedure: Laparoscopic distal pancreatectomy
Procedure: Open 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).
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).
Recurrence Free Survival
RFS
Time frame: 2 years
Overall Survival
OS
Time frame: 2 years
R0 resection rate
R0 resection rate
Time frame: 2 years
Detected lymph node number
Detected lymph node number
Time frame: 2 years
Plan to share: No
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Fudan University