An interventional study of pancreaticoduodenectomy in Pancreatic Cancer, Bile Duct Cancer and Ampulla of Vater Cancer, sponsored by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital. Completed at 1 site in Russia. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital · Not applicable, Interventional, and Treatment
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons.
Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial.
In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 320 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Procedure: pancreaticoduodenectomy
Procedure: pancreaticoduodenectomy
Procedure: pancreaticoduodenectomy
Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation
Overall complications
The proportion of all complications after operation accounted for the total number of patients
Time frame: up to 30 days
Pancreatic fistula
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Time frame: up to 30 days
Intra-abdominal bleeding
he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Time frame: up to 30 days
Intra-abdominal infection
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Time frame: up to 30 days
Length of hospital stay (day)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time frame: Up to postoperative 2 months
progression-free survival
The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason
Time frame: Up to postoperative 3 years
Plan to share: No
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State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital