NCT06084975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

4.5 years

First QC Date

October 10, 2023

Last Update Submit

October 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • major complications

    (Clavien-Dindo grade ≥ III)

    Within 30 days of SP-MIDP

Study Arms (2)

Kimura technique (KT)

Spleen preservation is accomplished by sparing the splenic vessels.

Procedure: Splenic vessels preservation

Warshaw technique (WT)

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

Interventions

preservation the splenic vessels

Kimura technique (KT)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent SP-MIDP at our institution between July 2018 and December 2022 were enrolled consecutively.

You may qualify if:

  • pathological diagnosis of benign or low-grade malignant pancreas tumors.

You may not qualify if:

  • incomplete medical records,
  • history of previous splenectomy,
  • high-grade malignant pancreas tumors,
  • conversion to open DP (ODP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples Without DNA

Study Officials

  • Liang Tingbo

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

July 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations