Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

When pancreatic cancer of the body and tail is diagnosed, a distal pancreatectomy is planned. This operation can be performed with open surgery, or with laparoscopic surgery. This study is a multicenter randomized controlled trial to evaluate the operative outcomes and survival of open versus laparoscopic distal pancreatectomy for pancreatic cancer of the body and tail.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: t
View:

• Eastern Cooperative Oncology Group (ECOG) performance score 0-2

• Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features

• Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)

• Lesion (within pancreatic body and tail) is located to the left of the left branch of the hepatic portal vein

• No remote metastasis in preoperative imaging and not adjacent to the superior mesenteric vein, superior mesenteric artery, and abdominal artery

• Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon

• Patients with informed consent

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Jun Suh Lee, M.D. Ph.D.
rudestock@gmail.com
+82-10-2747-6320
Backup
Yoo-Seok Yoon, M.D. Ph.D.
arsyun@gmail.com
Time Frame
Start Date: 2019-05-20
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 244
Treatments
Experimental: Laparoscopic distal pancreatectomy
Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer
Active_comparator: open distal pancreatectomy
Patients receiving open distal pancreatectomy for pancreatic tail and body cancer
Sponsors
Collaborators: Seoul National University Bundang Hospital, Samsung Medical Center, Asan Medical Center, Seoul St. Mary's Hospital, Severance Hospital, Gangnam Severance Hospital
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov