Trial Outcomes & Findings for Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer (NCT NCT01774019)

NCT ID: NCT01774019

Last Updated: 2023-04-10

Results Overview

The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 284 participants
• Primary outcome timeframe: 120 to 150 days
• Results posted on: 2023-04-10

Participant Flow

Study participants were screened by site investigators at 11 academic medical centers globally between February 2013 and August 2021. The first participant was enrolled in February 2013 and the last participant was enrolled in August 2021.

Of the 765 participants assessed for eligibility, 284 met criteria and were randomized.

Participant milestones

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Overall Study STARTED	144	140
Overall Study COMPLETED	138	136
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Overall Study No longer meets protocol criteria	2	0
Overall Study Withdrawal by Subject	1	0
Overall Study Surgery delayed > 120 days	1	0
Overall Study Patient refused surgery	1	1
Overall Study Unable to implant study device	1	0
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=144 Participants Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) n=140 Participants Patients in this group will not receive pre-operative biliary drainage with a study SEMS	Total n=284 Participants Total of all reporting groups
Age, Continuous	61.9 Years STANDARD_DEVIATION 11.5 • n=144 Participants	64.9 Years STANDARD_DEVIATION 11.7 • n=140 Participants	63.4 Years STANDARD_DEVIATION 11.7 • n=284 Participants
Sex: Female, Male Female	64 Participants n=144 Participants	59 Participants n=140 Participants	123 Participants n=284 Participants
Sex: Female, Male Male	80 Participants n=144 Participants	81 Participants n=140 Participants	161 Participants n=284 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Hong Kong	52 participants n=144 Participants	51 participants n=140 Participants	103 participants n=284 Participants
Region of Enrollment Belgium	8 participants n=144 Participants	7 participants n=140 Participants	15 participants n=284 Participants
Region of Enrollment United States	4 participants n=144 Participants	3 participants n=140 Participants	7 participants n=284 Participants
Region of Enrollment Japan	9 participants n=144 Participants	7 participants n=140 Participants	16 participants n=284 Participants
Region of Enrollment China	2 participants n=144 Participants	2 participants n=140 Participants	4 participants n=284 Participants
Region of Enrollment Italy	27 participants n=144 Participants	27 participants n=140 Participants	54 participants n=284 Participants
Region of Enrollment Australia	3 participants n=144 Participants	3 participants n=140 Participants	6 participants n=284 Participants
Region of Enrollment France	3 participants n=144 Participants	3 participants n=140 Participants	6 participants n=284 Participants
Region of Enrollment India	36 participants n=144 Participants	37 participants n=140 Participants	73 participants n=284 Participants
Height	163.3 cm STANDARD_DEVIATION 9.1 • n=144 Participants	161.8 cm STANDARD_DEVIATION 8.7 • n=140 Participants	162.5 cm STANDARD_DEVIATION 8.9 • n=284 Participants
Weight	65.0 kg STANDARD_DEVIATION 12.8 • n=144 Participants	63.2 kg STANDARD_DEVIATION 12.7 • n=140 Participants	64.1 kg STANDARD_DEVIATION 12.8 • n=284 Participants
BMI	24.3 kg/m^2 STANDARD_DEVIATION 3.9 • n=144 Participants	24.1 kg/m^2 STANDARD_DEVIATION 3.9 • n=140 Participants	24.2 kg/m^2 STANDARD_DEVIATION 3.9 • n=284 Participants
Karnofsky Score (overall health status)	91.3 units on a scale STANDARD_DEVIATION 7.3 • n=144 Participants	89.6 units on a scale STANDARD_DEVIATION 9.1 • n=140 Participants	90.5 units on a scale STANDARD_DEVIATION 8.2 • n=284 Participants
Total serum bilirubin	14.0 mg/dl STANDARD_DEVIATION 6.3 • n=144 Participants	12.9 mg/dl STANDARD_DEVIATION 5.0 • n=140 Participants	13.4 mg/dl STANDARD_DEVIATION 5.7 • n=284 Participants
Tumor location on imaging Head	102 Participants n=144 Participants	85 Participants n=140 Participants	187 Participants n=284 Participants
Tumor location on imaging Ampullary	30 Participants n=144 Participants	34 Participants n=140 Participants	64 Participants n=284 Participants
Tumor location on imaging distal	12 Participants n=144 Participants	16 Participants n=140 Participants	28 Participants n=284 Participants
Tumor location on imaging Uncinate process	0 Participants n=144 Participants	2 Participants n=140 Participants	2 Participants n=284 Participants
Tumor location on imaging Isthmus	0 Participants n=144 Participants	1 Participants n=140 Participants	1 Participants n=284 Participants
Tumor location on imaging tail	0 Participants n=144 Participants	1 Participants n=140 Participants	1 Participants n=284 Participants
Tumor location on imaging Duodenum	0 Participants n=144 Participants	1 Participants n=140 Participants	1 Participants n=284 Participants

PRIMARY outcome

Timeframe: 120 to 150 days

The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.

Outcome measures

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=138 Participants Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) n=136 Participants Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last	40 Participants	36 Participants

SECONDARY outcome

Timeframe: Procedure

Population: 3 patients in the WallFlex Biliary RX Fully Covered/Uncovered Stent arm had no stent placed. Patients in the no drainage arm are not intended to have a stent placement per protocol.

Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent)

Outcome measures

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=141 Participants Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Stent Placement Success	140 Participants	—

SECONDARY outcome

Timeframe: 120 to 150 days

Count of patients with biliary interventions after baseline

Outcome measures

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=144 Participants Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) n=140 Participants Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Number of Patients With Biliary Re-interventions	8 Participants	12 Participants

SECONDARY outcome

Timeframe: 4 weeks

This is the number of patients that had successful resection

Outcome measures

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=118 Participants Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) n=129 Participants Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Success Rate of Curative Intent Surgery	103 Participants	115 Participants

SECONDARY outcome

Timeframe: 150 days

Mortality which occurs within 150 days of baseline

Outcome measures

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=144 Participants Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) n=140 Participants Patients in this group will not receive pre-operative biliary drainage with a study SEMS
All-cause Mortality	11 Participants	11 Participants

Adverse Events

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Serious events: 40 serious events

Other events: 0 other events

Deaths: 11 deaths

None (No Pre-Operative Biliary Drainage)

Serious events: 36 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	WallFlex™ Biliary RX Fully Covered/Uncovered Stent System n=144 participants at risk Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) WallFlex™ Biliary RX Fully Covered/Uncovered Stent System	None (No Pre-Operative Biliary Drainage) n=140 participants at risk Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Hepatobiliary disorders Cholangitis	2.8% 4/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	4.3% 6/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Gastrointestinal disorders Pancreatitis	4.9% 7/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Vascular disorders Hemorrhage after ERCP	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Cardiac disorders Myocardial Infarction	1.4% 2/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Investigations Biliary obstruction	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
General disorders Fever	2.8% 4/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Infection	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
General disorders Left leg swelling	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Hepatobiliary disorders Persistent jaundice	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Respiratory infection	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Septic arthritis	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Nervous system disorders Stroke	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Injury, poisoning and procedural complications Subdural hematoma	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Injury, poisoning and procedural complications Hemorrhage after CIS	2.1% 3/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	7.1% 10/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Intra-abdominal abscess	2.8% 4/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	5.7% 8/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Injury, poisoning and procedural complications Pancreaticojejunostomy leakage	2.8% 4/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	2.9% 4/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Sepsis	1.4% 2/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	2.9% 4/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Injury, poisoning and procedural complications Biliary leakage	1.4% 2/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	1.4% 2/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Gastrointestinal disorders Delayed gastric emptying	1.4% 2/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	1.4% 2/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Wound infection	1.4% 2/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	1.4% 2/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Gastrointestinal disorders Ascites	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Metabolism and nutrition disorders Diabetes	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	1.4% 2/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Injury, poisoning and procedural complications Gastrojejunostomy or duodenojejunostomy leakage	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	1.4% 2/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Gastrointestinal disorders Small bowel obstruction	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Psychiatric disorders Delirium	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Hepatobiliary disorders Hepatic artery thrombosis	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Metabolism and nutrition disorders Hypoglycemia	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Vascular disorders Hypovolemia	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Gastrointestinal disorders Pain	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Injury, poisoning and procedural complications Pancreaticogastrostomy leakage	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Pneumonia	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Infections and infestations Pyelonephritis	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Vascular disorders Refractory shock	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.71% 1/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
Nervous system disorders Right hemiplegia	0.69% 1/144 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.	0.00% 0/140 • All serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.

Other adverse events

Adverse event data not reported

Additional Information

Andrea Burbage

Boston Scientific

Phone: 15086834387

Email: Andrea.Burbage@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place