Trial Outcomes & Findings for Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy (NCT NCT02238847)
NCT ID: NCT02238847
Last Updated: 2020-02-17
Results Overview
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
WallFlex Biliary RX Fully Covered Stent System
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
|
Overall Study
COMPLETED
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
22
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=59 Participants
|
65.0 years
n=60 Participants
|
65 years
n=119 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=59 Participants
|
27 Participants
n=60 Participants
|
53 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=59 Participants
|
33 Participants
n=60 Participants
|
66 Participants
n=119 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
77.7 kg
n=59 Participants
|
78.4 kg
n=60 Participants
|
78 kg
n=119 Participants
|
|
Gallbladder in Situ
|
43 Participants
n=59 Participants
|
42 Participants
n=60 Participants
|
85 Participants
n=119 Participants
|
|
Karnofsky Score (overall health status)
|
90.0 units on a scale
n=59 Participants
|
80.0 units on a scale
n=60 Participants
|
90 units on a scale
n=119 Participants
|
|
Tumor Size
|
3.1 cm
STANDARD_DEVIATION 1.4 • n=59 Participants
|
2.9 cm
STANDARD_DEVIATION 50.9 • n=60 Participants
|
3.0 cm
STANDARD_DEVIATION 1.2 • n=119 Participants
|
|
Tumor Stage
IA - T1 N0 M0
|
7 Participants
n=59 Participants
|
3 Participants
n=60 Participants
|
10 Participants
n=119 Participants
|
|
Tumor Stage
IB - T2 N0 M0
|
5 Participants
n=59 Participants
|
6 Participants
n=60 Participants
|
11 Participants
n=119 Participants
|
|
Tumor Stage
IIA - T3 N0 M0
|
19 Participants
n=59 Participants
|
24 Participants
n=60 Participants
|
43 Participants
n=119 Participants
|
|
Tumor Stage
IIB - T1 N1 M0; T2 N1 M0; T3 N1 M0
|
15 Participants
n=59 Participants
|
15 Participants
n=60 Participants
|
30 Participants
n=119 Participants
|
|
Tumor Stage
III - T4 Any N M0
|
5 Participants
n=59 Participants
|
5 Participants
n=60 Participants
|
10 Participants
n=119 Participants
|
|
Tumor Stage
Unknown
|
8 Participants
n=59 Participants
|
7 Participants
n=60 Participants
|
15 Participants
n=119 Participants
|
|
Number of participants who underwent curative intent surgery
|
24 Participants
n=59 Participants
|
27 Participants
n=60 Participants
|
51 Participants
n=119 Participants
|
|
Number of participants not undergoing curative intent surgery&followed to 1year post-stent placement
|
30 Participants
n=59 Participants
|
32 Participants
n=60 Participants
|
62 Participants
n=119 Participants
|
PRIMARY outcome
Timeframe: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)Population: Participant was eligible for primary endpoint analysis if participant did not undergo biliary reintervention from time of SEMS placement to CIS, or from time of SEMS placement to one year after SEMS placement (for participants not undergoing CIS).
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=54 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=59 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
|
39 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: From stent placement procedure up to one year after stent placement procedureSerious adverse events related to the stent placement procedure or to the stent
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Procedure-related or Stent-related Serious Adverse Events
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During the Stent Placement ProcedureTechnical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Technical Success
|
58 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CISPopulation: Of 59 participants in the Fully Covered arm, neoadjuvant therapy information was only provided for 55 participants. Of 60 participants in the Uncovered arm, neoadjuvant therapy information was only provided for 52 participants.
The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=55 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=52 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
|
53 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CISThe number of participants with stent migration
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Number of Participants With Stent Migration
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the time of curative intent surgery (CIS) (median 110 days to CIS)Population: Of 59 Participants in Fully Covered Arm, 24 underwent Curative Intent Surgery. Of 60 Participants in Uncovered Arm, 27 underwent Curative Intent Surgery.
The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=24 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=27 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From stent placement to one year after stent placement for participants not undergoing curative intent surgeryPopulation: 30 participants in the Fully Covered arm did not undergo curative intent surgery and were followed for one year. 32 participants in the Uncovered arm did not undergo curative intent surgery and were followed for one year.
For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=30 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=32 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
|
19 Participants
|
21 Participants
|
POST_HOC outcome
Timeframe: Measured at any point during stent indwell - until curative intent surgery (CIS) (median 110 days to CIS) or one year post stent placement (for participants not underoing CIS)The number of participants with tumor ingrowth at any point during stent indwell.
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Number of Participants With Tumor Ingrowth
|
0 Participants
|
10 Participants
|
POST_HOC outcome
Timeframe: From stent placement up to curative intent surgery (CIS) (median 110 days to CIS), or from stent placement up to one year post stent placement for participants not undergoing CISPopulation: 43/59 participants in Fully Covered Arm and 42/60 participants in Uncovered Arm had gallbladder in situ. Therefore, Acute Cholecystitis only analyzed in 43 participants in Fully Covered Arm and 42 participants in Uncovered Arm.
The number of participants with acute cholecystitis
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=43 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=42 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Number of Participants With Acute Cholecystitis
|
4 Participants
|
2 Participants
|
POST_HOC outcome
Timeframe: From randomization to one year after randomizationThe mortality at one year after randomization.
Outcome measures
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 Participants
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 Participants
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Mortality at One Year After Randomization
|
21 Participants
|
25 Participants
|
Adverse Events
WallFlex Biliary RX Fully Covered Stent System
Serious events: 14 serious events
Other events: 0 other events
Deaths: 21 deaths
WallFlex Biliary RX Uncovered Stent System
Serious events: 12 serious events
Other events: 0 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
WallFlex Biliary RX Fully Covered Stent System
n=59 participants at risk
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
WallFlex Biliary RX Uncovered Stent System
n=60 participants at risk
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
|
|---|---|---|
|
Hepatobiliary disorders
Acute Cholecystitis
|
6.8%
4/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
3.3%
2/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
1.7%
1/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
0.00%
0/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
|
Hepatobiliary disorders
Cholangitis
|
15.3%
9/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
13.3%
8/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
1.7%
1/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
0.00%
0/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
1/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
3.3%
2/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
|
Hepatobiliary disorders
CBD Obstruction or Abnormal LFTs
|
3.4%
2/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
1.7%
1/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/59 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
1.7%
1/60 • Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).
Reported on all treatment related Serious Adverse Events
|
Other adverse events
Adverse event data not reported
Additional Information
Lina Ginnetti, Clinical Endoscopy Director
Boston Scientific Corporation
Phone: 508-683-4512
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60