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NCT03792932

Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Status unknown NA Last updated 22 June 2022
What this trial tests

NA trial testing Laparoscopic distal pancreatectomy in Pancreatic Cancer in 306 participants. Status unknown.

Timeline
2 February 2019
Primary endpoint
31 January 2023
31 January 2023

Quick facts

Lead sponsorFudan University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment306
Start date2 February 2019
Primary completion31 January 2023
Estimated completion31 January 2023
Sites11 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Fudan University

Who can join

Adults 19 to 80, any sex, with Pancreatic Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Landmark Series: Minimally Invasive Pancreatic Resection.
    van Hilst J, de Graaf N, Abu Hilal M, Besselink MG. · · 2021 · cited 35× · PMID 33341916 · DOI 10.1245/s10434-020-09335-3
  2. Minimally invasive versus open pancreatic surgery: meta-analysis of randomized clinical trials.
    Pfister M, Probst P, Müller PC, Antony P, et al · · 2023 · cited 25× · PMID 36967469 · DOI 10.1093/bjsopen/zrad007
  3. Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial.
    van Hilst J, Korrel M, Lof S, de Rooij T, et al · · 2021 · cited 25× · PMID 34503548 · DOI 10.1186/s13063-021-05506-z
  4. Predictors for Survival in an International Cohort of Patients Undergoing Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma.
    Korrel M, Lof S, van Hilst J, Alseidi A, et al · · 2021 · cited 13× · PMID 32583198 · DOI 10.1245/s10434-020-08658-5
  5. Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open DIStal PAnCreaTectomy (DISPACT-2 trial).
    Probst P, Schuh F, Dörr-Harim C, Sander A, et al · · 2021 · cited 7× · PMID 33619204 · DOI 10.1136/bmjopen-2020-047867
  6. Effect of Laparoscopic Versus Open Distal Pancreatectomy on Recurrence-free Survival in Patients With Left-sided Pancreatic Cancer: A Randomized Controlled Trial.
    Liu C, Cheng H, Wang M, Cai Y, et al · · 2025 · cited 1× · PMID 39996303 · DOI 10.1097/sla.0000000000006681
  7. Minimally Invasive versus Open Distal Pancreatectomy in the 2020s: Recent Institutional Experience and a Narrative Review of Current Evidence.
    Rehman S, Patel I, Bartlett D, Mirza D. · · 2023 · cited 1× · PMID 37892716 · DOI 10.3390/jcm12206578

Verify or expand the search:

Other trials of Laparoscopic distal pancreatectomy

Trials testing the same drug.

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Other Fudan University trials

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Data sources for this page

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