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Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy

Sponsor
Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT06084975
Collaborator
(none)
314
Enrollment
1
Location
54
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Spleen-persevering distal pancreatectomy (SP-DP) has been widely advocated as a routine procedure for benign or low-grade malignant tumors in the pancreatic body and tail, especially with a minimally invasive approach. Spleen preservation can be accomplished with Kimura technique (KT) or Warshaw technique (WT) Both of the two techniques were proved to be feasible and efficient. However, the perioperative outcomes and long-term benefits between patients with KT and WT in spleen-persevering minimally invasive distal pancreatectomy (SP-MIDP) remains controversial.

Several small series have reported a slightly higher prevalence of postpancreatectomy hemorrhage (PPH) in patients who undergo KT than those undergo WT. The exposure of splenic vessels to erosive pancreatic juice and the preservation of splenic vessels itself may explain the higher chance of PPH in KT. Larger volume studies are warranted to confirm this finding and to clarify the clinical significance. This study compared the perioperative outcomes between the two spleen-preserving techniques, with a focus on parameters relating to perioperative patient safety. Especially, the incidence and clinical relevance of PPH in SP-MIDP were evaluated.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Splenic vessels preservation

Study Design

Study Type:
Observational
Actual Enrollment :
314 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy: With a Specific Focus on Perioperative Patient Safety
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Kimura technique (KT)

Spleen preservation is accomplished by sparing the splenic vessels.

Procedure: Splenic vessels preservation
preservation the splenic vessels
Warshaw technique (WT)

Spleen preservation is accomplished by sacrificing the splenic vessels and maintaining vascularity through the preserved short gastric and left gastroepiploic vessels.

Outcome Measures

Primary Outcome Measures

  1. major complications [Within 30 days of SP-MIDP]

    (Clavien-Dindo grade ≥ III)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • pathological diagnosis of benign or low-grade malignant pancreas tumors.
Exclusion Criteria:

  • incomplete medical records,

  • history of previous splenectomy,

  • high-grade malignant pancreas tumors,

  • conversion to open DP (ODP).

Contacts and Locations

Locations

Site City State Country Postal Code
1 the First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • Zhejiang University

Investigators

  • Principal Investigator: Liang Tingbo, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TingBo Liang, Professor, Zhejiang University
ClinicalTrials.gov Identifier:
NCT06084975
Other Study ID Numbers:
  • SP-MIDP
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemorrhage

Study Results

No Results Posted as of Oct 16, 2023