Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119776
Collaborator
(none)
70
1
60
1.2

Study Details

Study Description

Brief Summary

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Whipple over the splenic artery
  • Procedure: Total pancreatectomy

Detailed Description

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Methods: The study group comprised 40 consecutive patients who underwent WOTSA for PDAC. Their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent TP between.

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
Actual Study Start Date :
May 20, 2020
Actual Primary Completion Date :
May 20, 2020
Anticipated Study Completion Date :
May 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Study

Patients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC

Procedure: Whipple over the splenic artery
Treatment for pancreatic ductal cell adenocarcinoma

Control

Patients who underwent total pancreatectomy (TP) as a treatment for PDAC

Procedure: Total pancreatectomy
Treatment for pancreatic ductal cell adenocarcinoma

Outcome Measures

Primary Outcome Measures

  1. Clinicopathological characteristics [before]

    Measurement of the remnant pancreatic volume

  2. Clinicopathological characteristics [1 week after the operation]

    Measurement of the remnant pancreatic volume

Secondary Outcome Measures

  1. Postoperative chemotherapy and follow-up [1 month after the operation]

    Measurement of the remnant pancreatic volume and physiological parameters

Other Outcome Measures

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [1 day before the operation]

    Measurement of the physiological parameters

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [3 months after the operation]

    Measurement of the physiological parameters

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [6 months after the operation]

    Measurement of the physiological parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • pancreatic ductal cell adenocarcinoma (PDCA) patients
Exclusion Criteria:
  • Patient undergoing palliative pancreatectomy, other malignancies with distant metastases

  • Vulnerable groups

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT06119776
Other Study ID Numbers:
  • 202004002RINA
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Aug 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
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023