Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The goal of this observational study is to determine how often lymph node metastases occur in the splenic hilum and surrounding fat in patients with left-sided pancreatic cancer.

The main question the study aims to answer is:

Is spleen removal necessary in all cases, or is the risk of lymph node metastases in the fat around the spleen low enough to reconsider this standard practice?

Currently, spleen removal is part of the standard treatment for patients with left-sided pancreatic cancer to ensure that any potential lymph node metastases in the surrounding fat are also removed. However, the likelihood of metastases in this area is low, and spleen removal carries risks.

This study is a first step toward changing the treatment approach. If the findings show that metastases in the fat around the spleen are rare, the next step will be a randomized trial to further investigate whether spleen removal is necessary.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All consecutive adult patients (≥ 18 years) who undergo an open or minimally invasive (i.e., robot-assisted or laparoscopic) left-sided pancreatectomy with concomitant splenectomy for primary resectable, borderline resectable, and locally advanced left-sided PDAC

Disqualifiers

Tumor involvement or abutment of the spleen

Trial population

Patients from hospitals performing pancreatic surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Lymph node metastasis in spleen-part

Time frame
1 month

Secondary outcomes

1

Predictors for the occurrence of lymph node metastasis in the spleen-part

A regression analysis will be performed to determine the predictors for the lymph node metastasis in the spleen part

Time frame
1 month
2

Overall and disease-free survival

Overall survival was defined as the time interval from surgery to death from any cause, and disease-free survival was defined as the time between surgery to either recurrence or death from any cause. 1-year, 2-year, and 5-year survival rates will be determined. Also the cause of death will be described.

Time frame
1 year, 2 years, 5 years
3

Predictors for overall and disease-free survival

A multivariable regression analysis will determine independent prognostic factors for overall and disease-free survival (including whether lymph node metastases in the spleen part are an independent prognostic factor).

Time frame
1-year, 2-year, and 5-year
4

Recurrence

Time frame
1 year, 2 years, 5 years

Other outcomes

Sponsors and contacts

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