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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2025
  • participants needed
    244
  • sponsor
    Seoul National University Hospital
Updated on 10 February 2022
Accepts healthy volunteers

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

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

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

When =5%, 1-=80%, =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

Details
Condition Pancreas Neoplasm Malignant Resectable
Treatment Laparoscopic distal pancreatectomy, open distal pancreatectomy
Clinical Study IdentifierNCT03957135
SponsorSeoul National University Hospital
Last Modified on10 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
No evidence of distant metastasis
No direct invasion of adjacent structures, with the exception of mesocolon or left adrenal gland
Possible to achieve a negative margin from adjacent major vasculature (Common hepatic artery, superior mesenteric artery, celiac axis, superior mesenteric vein - portal vein)
Eastern Cooperative Oncology Group (ECOG) performance score 0-2
Patients with informed consent

Exclusion Criteria

History of other malignancy (with the exception of more than 5 year interval, with no evidence of recurrence)
Necessity of resection of other abdominal organs
Recurrent pancreatic cancer
Neoadjuvant chemotherapy
Comorbidities with a high risk for general anesthesia
Other subject whom the investigator deems inappropriate
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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