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出境医 / 临床实验 / Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasm Malignant Resectable Procedure: Laparoscopic distal pancreatectomy Procedure: open distal pancreatectomy Not Applicable

Detailed 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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Laparoscopic distal pancreatectomy
Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer
 Procedure: Laparoscopic distal pancreatectomy
Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
Active Comparator: open distal pancreatectomy
Patients receiving open distal pancreatectomy for pancreatic tail and body cancer
 Procedure: open distal pancreatectomy
Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer
Outcome Measures
Primary Outcome Measures :
  1. 2 year survival [ Time Frame: 2 years ]
    Overall survival at 2 years after surgery


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jun Suh Lee, M.D. Ph.D. +82-10-2747-6320 rudestock@gmail.com
Contact: Yoo-Seok Yoon, M.D. Ph.D. arsyun@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Kyeonggi-do, Korea, Republic of, 13620
Contact: Jun Suh Lee, M.D., Ph.D.    +82-10-2747-6320    rudestock@gmail.com   
Principal Investigator: Ho-Seong Han, M.D.,Ph.D.         
Sub-Investigator: Yoo-Seok Yoon, M.D.,Ph.D.         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Severance Hospital
Asan Medical Center
Seoul St. Mary's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ho-Seong Han, M.D. Ph.D. Seoul National University Bundang Hospital
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE May 20, 2019
Estimated Primary Completion Date November 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019) 		2 year survival [ Time Frame: 2 years ]
Overall survival at 2 years after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Versus Open Distal Pancreatectomy for Pancreatic Cancer: a Multicenter Randomized Controlled Trial
Official Title  ICMJE Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail
Brief 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.
Detailed 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective randomized controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreas Neoplasm Malignant Resectable
Intervention  ICMJE
  • Procedure: Laparoscopic distal pancreatectomy
    Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
  • Procedure: open distal pancreatectomy
    Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer
Study Arms  ICMJE
  • Experimental: Laparoscopic distal pancreatectomy
    Patients receiving laparoscopic distal pancreatectomy for pancreatic tail and body cancer
    Intervention: Procedure: Laparoscopic distal pancreatectomy
  • Active Comparator: open distal pancreatectomy
    Patients receiving open distal pancreatectomy for pancreatic tail and body cancer
    Intervention: Procedure: open distal pancreatectomy
Publications *
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019) 		244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2025
Estimated Primary Completion Date November 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jun Suh Lee, M.D. Ph.D. +82-10-2747-6320 rudestock@gmail.com
Contact: Yoo-Seok Yoon, M.D. Ph.D. arsyun@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957135
Other Study ID Numbers  ICMJE SNUBH-GS-HBP4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ho-Seong Han, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Seoul National University Bundang Hospital
  • Severance Hospital
  • Asan Medical Center
  • Seoul St. Mary's Hospital
Investigators  ICMJE
Principal Investigator: Ho-Seong Han, M.D. Ph.D. Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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