Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial

Pancreas Neoplasm Malignant Resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957135
• Other study ID #: SNUBH-GS-HBP4
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: November 30, 2025

Study information

• Verified date: September 2022
• Source: Seoul National University Hospital
• Contact: Jun Suh Lee, M.D. Ph.D.
• Phone: +82-10-2747-6320
• Email: rudestock[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• Purpose

To compare the safety and oncologic feasibility of open versus laparoscopic distal pancreatectomy for the treatment of pancreatic ductal adenocarcinoma (PDAC) of the body and tail.

• Study method

Multicenter prospective randomized controlled trial Noninferiority analysis Patients diagnosed with PDAC of the body and tail, without evidence of distant metastasis or direct invasion of adjacent organs, will be randomly allocated to either the open distal pancreatectomy group or the laparoscopic distal pancreatectomy group. Postoperative outcomes and survival data will be analyzed.

• Number of subjects

Sample size was calculated based on 2 year survival after pancreatectomy.

pA: 2 year survival of open distal pancreatectomy pB: 2 year survival of laparoscopic distal pancreatectomy

Null hypothesis: The 2 year survival of laparoscopic distal pancreatectomy is inferior to that of open distal pancreatectomy. H0: pA-pB≥δ

Alternative hypothesis: The 2 year survival of laparoscopic distal pancreatectomy is not inferior to that of open distal pancreatectomy. H1: pA-pB<δ

2 year survival of pancreatectomy (Shin et al, 2015) is 55.9% for open and 64.3% for laparoscopic distal pancreatectomy.

When α=5%, 1-β=80%, δ=10%, and one-sided analysis is performed with a power of 80%, the required number of subjects is 111 for each group.

With a drop rate of 10%, the final number of each group is 122, with a total of 244.

• Primary and Secondary endpoints

Primary endpoint: 2 year overall survival

Secondary endpoint: R0 resection rate, 2 year disease free survival, 2 year recurrence rate, complication rate, postoperative hospital stay, operative time, estimated blood loss

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with remote metastasis at the time of diagnosis of pancreatic cancer

• History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)

• In the case of invasion of other organs other than the left adrenal gland and mesocolon

• Where major vascular resection, such as the portal vein or abdominal artery, is required to secure negative resection

• Recurrent pancreatic cancer

• Patients with underlying diseases at high risk of general anesthesia

• Preperitoneal or other organ metastases found during surgery

• In case of previously undergone pancreatic resection

• Other subject whom the investigator deems inappropriate

Related Conditions & MeSH terms

• Neoplasms
• Pancreas Neoplasm Malignant Resectable
• Pancreatic Neoplasms

Intervention

Procedure:
• Laparoscopic distal pancreatectomy
Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
• open distal pancreatectomy
Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Kyeonggi-do

Sponsors (7)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Gangnam Severance Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Shin SH, Kim SC, Song KB, Hwang DW, Lee JH, Lee D, Lee JW, Jun E, Park KM, Lee YJ. A comparative study of laparoscopic vs. open distal pancreatectomy for left-sided ductal adenocarcinoma: a propensity score-matched analysis. J Am Coll Surg. 2015 Feb;220(2):177-85. doi: 10.1016/j.jamcollsurg.2014.10.014. Epub 2014 Oct 31. — View Citation

Yoon YS, Lee KH, Han HS, Cho JY, Ahn KS. Patency of splenic vessels after laparoscopic spleen and splenic vessel-preserving distal pancreatectomy. Br J Surg. 2009 Jun;96(6):633-40. doi: 10.1002/bjs.6609. — View Citation

Yoon YS, Lee KH, Han HS, Cho JY, Jang JY, Kim SW, Lee WJ, Kang CM, Park SJ, Han SS, Ahn YJ, Yu HC, Choi IS. Effects of laparoscopic versus open surgery on splenic vessel patency after spleen and splenic vessel-preserving distal pancreatectomy: a retrospective multicenter study. Surg Endosc. 2015 Mar;29(3):583-8. doi: 10.1007/s00464-014-3701-9. Epub 2014 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year survival	Overall survival at 2 years after surgery	2 years