Trial Outcomes & Findings for SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice (NCT NCT03820544)

NCT ID: NCT03820544

Last Updated: 2025-04-30

Results Overview

The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

At 30 days post-surgery

Results posted on

2025-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	SEMS Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection. Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement	Standard of Care Surgical Resection Patients undergo standard of care surgical resection. Standard of care: Undergo standard of care surgical resection
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At 30 days post-surgery

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

The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At time of surgery

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

Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.

Outcome measures

Outcome data not reported

Adverse Events

SEMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Surgical Resection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Kowalski, MD

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-9396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SEMS n=2 Participants Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection. Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement	Standard of Care Surgical Resection n=2 Participants Patients undergo standard of care surgical resection. Standard of care: Undergo standard of care surgical resection	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants