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Completed

NCT Number: NCT04325152

Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP

Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.

We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.

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Key information

Conditions

Pancreaticobiilary Diseases Endoscopic Retrograde Cholangiopancreatography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiamen Humanity Hospital, Xiamen, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80
  • Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.

Exclusion criteria

  • Expected life span ≤6 months
  • Considering tumor resection within 6 months
  • Failed CBD cannulation
  • Hilar stricture (Bismuth II, III and IV)
  • CBD dilating by a balloon catheter with diameter≥8mm
  • Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
  • Maximal CBD diameter ≤6mm
  • Pregnancy or lactation
  • Unable to provide informed consent

Treatment and study plan

FCSEMS plus Clip

Device

After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.

FCSEMS

Device

FCSEMS was released as the same as mentioned above. No fixating method was used.

Primary outcomes

  1. Migration rate of FCSEMS

    Time frame: 6 months

    The proportion of patients who had stent migration after placing FCSEMS, which was defined as radiological or endoscopic evidence of distal or proximal migration within 6 months after placing FCSEMS.

Secondary outcomes

  1. Distal migration rate

    Time frame: 6 months

    The proportion of patients who had distal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially distal migration of the stent out of CBD during follow up.

    Fully distal migration: The whole stent was out of CBD or disappeared in fluoroscopy.

    Partially distal migration: More than half length of FCSEMS was visible in endoscopic view.

  2. Proximal migration rate

    Time frame: 6 months

    The proportion of patients who had proximal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially proximal migration of the stent into CBD during follow up.

    Fully proximal migration: The whole stent was in CBD and the distal end was not visible.

    Partially proximal migration: Less than 0.5cm of distal end of FCSEMS was visible in endoscopic view.

  3. Rate of cholangitis after FCSEMS placement

    Time frame: 6 months

    The proportion of patients who had the complication of cholangitis during follow up, due to stent migration, tumor/tissue ingrowth or food impaction.

  4. Complications related to stent removal

    Time frame: 6 months

    Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Collaborators

  • Eastern Hepatobiliary Surgery Hospital
  • Huaihe Hospital of Henan University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Xiamen Humanity Hospital

Registry information

Official study title

Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2020
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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