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Completed

NCT Number: NCT06981975

Long-Term Outcomes of Different Stents for Benign Biliary Strictures Caused by Chronic Pancreatitis

This observational study aims to observe and compare the long-term effectiveness and safety of different types of stents for benign biliary strictures secondary to chronic pancreatitis.

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Key information

Conditions

Chronic Pancreatitis Benign Biliary Strictures Chronic Disease Digestive System Diseases Disease Attributes ERCP ESWL Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Stenting Treatment

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

Chronic pancreatitis (CP) is a debilitating condition that often results in the development of benign biliary strictures (BBS), which significantly contribute to morbidity. BBS are prevalent among a substantial number of CP patients, causing complications such as cholestasis and jaundice. Endoscopic biliary stenting has traditionally been the primary treatment for BBS, initially employing single plastic stents (SPS), which yielded suboptimal outcomes.

Nowadays, fully covered self-expanding metal stents (fcSEMS) and multiple plastic stents (MPS) are considered the first line therapies for BBS caused by CP. However, advancements in lithotripsy and endoscopic retrograde cholangiopancreatography have led to a marked increase in the successful rate of pancreatic duct decompression. This progress necessitates a reevaluation of the effectiveness of SPS.

The objective of this study is to assess and compare the long-term outcomes of various stenting types in patients with BBS due to CP. It is expected that the study's results will provide valuable insights into the optimal stenting strategies for BBS in CP patients. These insights have the potential to greatly influence clinical practice and guide the development of treatment guidelines.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of chronic pancreatitis
  • Benign biliary strictures secondary to chronic pancreatitis
  • Patients who have undergone endoscopic biliary stenting for the management of BBS between January 2011 and December 2021.
  • Complete Treatment Records

Exclusion criteria

  • Patients diagnosed with pancreatic cancer within two years following the diagnosis of CP.
  • Incomplete Records of endoscopic biliary stenting treatment

Treatment and study plan

single plastic stent

Device

Endoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of a single plastic stent. Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary.

Other names: SPS

Multiple plastic stents

Device

Endoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of multiple plastic stents. Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary.

Other names: MPSs

Fully covered self-expanding metal stents

Device

Endoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of fully covered self-expanding metal stents (fcSEMS) . Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary.

Other names: fcSEMS

Primary outcomes

  1. Long-term clinical success

    Time frame: 14 year follow up

    Being recurrence-free from the time of initial stent removal or spontaneous stent passage

Secondary outcomes

  1. Early clinical success

    Time frame: 1 year since the initial procedure

    Benign biliary stricture resolution within 1 year since the initial procedure

  2. Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures

    Time frame: 14 year follow up

    Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures during the initial treatment period (excluding ERCP treatment after stricture recurrence)

  3. Total number of stents placed

    Time frame: 14 year follow up

    Total number of stents placed during the initial treatment period (excluding stents placed for stricture recurrence)

  4. Total stenting time

    Time frame: 14 year follow up

    Total stents placement duration of the initial treatment period (from stent placement to stent removal or spontaneous passage)

  5. Technical success

    Time frame: 14 year follow up

    Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.

  6. Stricture recurrence

    Time frame: 14 year follow up

    Abnormalities in liver function tests and the need for repeat intervention after a period of stent removal

  7. Procedure- or device-related adverse events

    Time frame: 14 year follow-up

    Device or procedure related serious adverse events from the initial stent placement procedure to the 14 year follow-up.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Long-term Outcomes of Different Stents for Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Comparative Study Based on a Large Prospective Cohort

Acronym: SOLID

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
Jun 4, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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