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Brief Title: RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors
Official Title: A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors
Study ID: NCT04037982
Brief Summary: 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.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Friendship Hospital, Capital medical University, Beijing, , China