Pancreatic CancerNCT03820544

SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

A study testing Endoscopic Retrograde Cholangiopancreatography in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Pancreatic Cancer
What is being tested?: Endoscopic Retrograde Cholangiopancreatography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2017to 4 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
Serum bilirubin > 10 mg/dl
Adequate birth control

Who cannot join

Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
Patients anticipated to require vascular reconstruction
Patients with cholangitis
Patients for whom surgery is deemed inappropriate by surgeon
Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL
Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC)

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Patients with low performance score (Karnofsky performance status scale < 50)
Patients with known preexisting liver disease with associated elevated bilirubin
Patients who are pregnant or actively breast feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice

This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.

Read the detailed description

PRIMARY OBJECTIVES:

To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (SEMS) and patients undergoing direct surgical resection.

Conditions: Pancreatic Cancer
Being tested: Endoscopic Retrograde Cholangiopancreatography, Standard of care
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic Retrograde CholangiopancreatographyProcedure or surgery
Also called ERCP
Undergo ERCP with SEMS placement
Standard of careOther
Undergo standard of care surgical resection

Study groups in NCT03820544
Study group	Role	What they receive
SEMS	Experimental	Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection. Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography
Standard of care surgical resection	Active comparator	Patients undergo standard of care surgical resection. Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Complication Rates of Grade III or Higher
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Measured: At 30 days post-surgery
Intraoperative Estimated Blood Loss
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20174 Apr 2019

First posted29 Jan 2019
Study start1 Sep 2017
Primary completion24 Jul 2018
Study completion4 Apr 2019

Why it stopped: Interest in this study changed and it was decided to end enrollment early

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03820544
Sponsor's protocol ID: 16D.759
Other IDs: JT 10199
Status last verified: Apr 2025
First submitted: 25 Jan 2019
Last updated: 30 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice
ClinicalTrials.gov ID: NCT03820544
Acronym / sponsor ID: 16D.759
Conditions: Pancreatic Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: Interest in this study changed and it was decided to end enrollment early
Enrolment: 4 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
Study start: 1 Sep 2017 (actual)
Primary completion: 24 Jul 2018 (actual)
Study completion: 4 Apr 2019 (actual)
First posted: 29 Jan 2019 (actual)
Results: Posted 10 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (SEMS) and patients undergoing direct surgical resection.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SEMS	Experimental	Procedure: Endoscopic Retrograde CholangiopancreatographyPatients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
Standard of care surgical resection	Active comparator	Other: Standard of carePatients undergo standard of care surgical resection.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
Serum bilirubin > 10 mg/dl
Adequate birth control

Key exclusion criteria (9 listed)

Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
Patients anticipated to require vascular reconstruction
Patients with cholangitis
Patients for whom surgery is deemed inappropriate by surgeon
Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endoscopic Retrograde CholangiopancreatographyAlso: ERCPUndergo ERCP with SEMS placement	Procedure or surgery	SEMS
Standard of careUndergo standard of care surgical resection	Other	Standard of care surgical resection

Primary outcome

Complication Rates of Grade III or Higher
Time frame: At 30 days post-surgery
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Intraoperative Estimated Blood Loss
Time frame: At time of surgery
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.

Results and safety

Results posted to the registry on 10 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SEMS	2	2
Standard of Care Surgical Resection	2	2

Primary outcome: Complication Rates of Grade III or Higher

Time frame: At 30 days post-surgery

Population analysed: Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.

Primary outcome: Intraoperative Estimated Blood Loss

Time frame: At time of surgery

Population analysed: Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.

Adverse events

Time frame: 1 year after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SEMS	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Standard of Care Surgical Resection	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Thomas Jefferson University HospitalLink provided by the sponsor.

Related trials for Pancreatic Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Kowalski, MD principal investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication Rates of Grade III or Higher (time frame: At 30 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03820544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.