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Study protocol
Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): Study protocol for a multicenter randomized controlled trial
Woo Hyun Paik
Seoul National University College of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8708-3280
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency. Although the expected patency of SEMS is around eight months, it has recently been reported that the duration of SEMS patency in patients using aspirin is prolonged. Our study therefore aims to confirm the effect of aspirin on SEMS patency. Methods This is an investigator-initiated, prospective, multicenter, double-blind, randomized placebo-controlled trial that will be conducted from November 2017 in four tertiary centers in South Korea. We intend to include in our study 184 adult (≥ 20 years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed. The patients will be randomly allocated to two groups, which will comprise patients who have either taken 100 mg aspirin or a placebo for six months after index ERBD. The primary outcome will be the rate of stent dysfunction, and the secondary outcomes will be the duration of patency, the rate of reintervention, and the occurrence of adverse events. Discussion The aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study will determine the efficacy of aspirin in maintaining metal stent patency in patients with malignant distal CBD obstructive.
Keywords
Endoscopic retrograde cholangiopancreatography, Self expandable metallic stents, Randomized controlled trial, Aspirin
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CURRENT STATUS: Published
Version 3
Posted 17 Jan, 2020
Published
On 30 Jan, 2020
No community comments so far
Editorial decision: Accept
On 18 Jan, 2020
Editor assigned
On 16 Jan, 2020
Submission checks complete
On 15 Jan, 2020
No comments provided
Editorial decision: Minor revision
On 14 Jan, 2020
Reviewer #2 agreed
On 09 Jan, 2020
Review #2 received
Received 09 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 29 Dec, 2019
No comments provided
Editorial decision: Major revision
On 10 Dec, 2019
Review #1 received
Received 06 Dec, 2019
Review #2 received
Received 02 Dec, 2019
Reviewer #2 agreed
On 20 Nov, 2019
Reviewer #3 agreed
On 20 Nov, 2019
Reviewer #1 agreed
On 19 Nov, 2019
Reviewers invited
Invitations sent on 19 Jul, 2019
Editor assigned
On 06 Jun, 2019
Submission checks complete
On 21 Mar, 2019
First submitted
On 11 Mar, 2019
Metrics
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PDF Downloads: ...
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Subject Areas
General Medicine
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): Study protocol for a multicenter randomized controlled trial
Woo Hyun Paik
Seoul National University College of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8708-3280
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 17 Jan, 2020
Published
On 30 Jan, 2020
No community comments so far
Editorial decision: Accept
On 18 Jan, 2020
Editor assigned
On 16 Jan, 2020
Submission checks complete
On 15 Jan, 2020
No comments provided
Editorial decision: Minor revision
On 14 Jan, 2020
Reviewer #2 agreed
On 09 Jan, 2020
Review #2 received
Received 09 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Review #1 received
Received 06 Jan, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 29 Dec, 2019
No comments provided
Editorial decision: Major revision
On 10 Dec, 2019
Review #1 received
Received 06 Dec, 2019
Review #2 received
Received 02 Dec, 2019
Reviewer #2 agreed
On 20 Nov, 2019
Reviewer #3 agreed
On 20 Nov, 2019
Reviewer #1 agreed
On 19 Nov, 2019
Reviewers invited
Invitations sent on 19 Jul, 2019
Editor assigned
On 06 Jun, 2019
Submission checks complete
On 21 Mar, 2019
First submitted
On 11 Mar, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency. Although the expected patency of SEMS is around eight months, it has recently been reported that the duration of SEMS patency in patients using aspirin is prolonged. Our study therefore aims to confirm the effect of aspirin on SEMS patency. Methods This is an investigator-initiated, prospective, multicenter, double-blind, randomized placebo-controlled trial that will be conducted from November 2017 in four tertiary centers in South Korea. We intend to include in our study 184 adult (≥ 20 years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed. The patients will be randomly allocated to two groups, which will comprise patients who have either taken 100 mg aspirin or a placebo for six months after index ERBD. The primary outcome will be the rate of stent dysfunction, and the secondary outcomes will be the duration of patency, the rate of reintervention, and the occurrence of adverse events. Discussion The aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study will determine the efficacy of aspirin in maintaining metal stent patency in patients with malignant distal CBD obstructive.
Figure 1
Figure 2