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

Distal Pancreatectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06084975
• Other study ID #: SP-MIDP
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Distal Pancreatectomy
• Hemorrhage

Intervention

Procedure:
• Splenic vessels preservation
preservation the splenic vessels

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major complications	(Clavien-Dindo grade = III)	Within 30 days of SP-MIDP