Pancreatic Cancer
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. 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.
Interventions
PROCEDUREEndoscopic Retrograde Cholangiopancreatography
Undergo ERCP with SEMS placement
OTHERStandard of care
Undergo standard of care surgical resection
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rates of Grade III or Higher | 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 | At time of surgery | Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| Standard of Care Surgical Resection Patients undergo standard of care surgical resection.
Standard of care: Undergo standard of care surgical resection | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | SEMS | Standard of Care Surgical Resection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Complication Rates of Grade III or Higher
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Time frame: 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.
Primary
Intraoperative Estimated Blood Loss
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
Time frame: 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.