Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

June 19, 2022 updated by: Xian-Jun Yu, Fudan University

A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail

Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Harbin, China
        • Recruiting
        • Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University
      • Shanghai, China
        • Recruiting
        • Department of Biliopancreatic Surgery, Huadong Hospital, Fudan University
        • Contact:
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
        • Contact:
          • chenlin zhu
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Department of Hepatobiliary and Pancreatic Surgery, The Second Hospital of Hebei Medical University
        • Contact:
          • Jianhua Liu
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Department of Hepatopancreatobiliary Surgery, Second Affiliated Hospital of Harbin Medical University,
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Department of Hepato-Pancreato-Biliary Surgery, The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Wenxing Zhao
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital
        • Contact:
    • Zhejiang
      • Hanzhou, Zhejiang, China
        • Recruiting
        • Department of Gastroenterology and Pancreatic Surgery, Zhejiang Provincial People's Hospital
        • Contact:
          • Weiwei Jin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 19 years and ≤ 80 years, no gender limitation
  2. Resectable body and tail pancreatic cancer (refer to NCCN 2018)
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. Tumor locates at the body and tail of the pancreas without distant metastasis
  5. No celiac trunk and superior mesenteric artery invasion
  6. No operation contraindication, fit for laparoscopic surgery
  7. The expected survival after surgery ≥ 3 months
  8. Patients who are willing and able to comply with the study procedure
  9. Signed informed content obtained prior to treatment

Exclusion Criteria:

  1. Locally advanced unresectable body and tail pancreatic cancer
  2. Multi-organ and vascular resection needed
  3. Patients undergoing total pancreatectomy
  4. Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
  5. Distant metastasis or ascites detected by imaging
  6. Severe important organ function impairment (heart, liver, kidney)
  7. Patients who are with other primary malignancy or haematological disorders
  8. Pregnant or nursing women
  9. Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
  10. Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic distal pancreatectomy
Procedure: Laparoscopic distal pancreatectomy
Laparoscopic distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
Active Comparator: Open distal pancreatectomy
Procedure: Open distal pancreatectomy
Open distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival
Time Frame: 2 years
RFS
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 years
OS
2 years
R0 resection rate
Time Frame: 2 years
R0 resection rate
2 years
Detected lymph node number
Time Frame: 2 years
Detected lymph node number
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2019

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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