An interventional study of laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy in Periampullary Tumor, Complication and Death, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment
Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.
Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preoperative imaging diagnosis of periampullary tumor, or preoperative pathological diagnosis of periampullary tumor, preoperative evaluation can be performed pancreaticoduodenectomy; Serum bilirubin was less than 100 μ mol/L before operation; Sign a written informed consent form and agree to be randomly divided into groups for surgical treatment.
In this group, patients will undergo laparoscopic pancreaticoduodenectomy.
Procedure: laparoscopic pancreaticoduodenectomy
In this group, patients will undergo open pancreaticoduodenectomy.
Procedure: Open pancreaticoduodenectomy
During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.
During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.
Incidence of complications
The patients number with complications / The total number in this group
Time frame: 30 days after operation
Plan to share: Yes
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital