Clinical trial NCT04503291: Comparison Between Transpapillary and Suprapapillary Metal Stent
Official title: Comparison Between Transpapillary and Suprapapillary Metal Stent Placement With Endoscopic Sphincterotomy in Common Bile Duct Malignant Obstruction: Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Common Bile Duct Stricture
Keywords: metal stent
common bile duct obstruction
endoscopic retrograde cholangiopancreatography
Lead sponsor: Bucheon St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: Incheon St.Mary's Hospital
name: St Vincent's Hospital
First posted: 2020-08-07
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. supra-papillary metal stent group
2. trans-papillary metal stent group
Primary purpose: TREATMENT

Brief summary: If surgical treatment is not possible in patients with malignant obstruction in the common bile duct, placing metal stents using endoscopy is a standardized treatment to resolve biliary obstruction. The metal stent is located in the bile duct to cover the stenotic portion by malignant tumors.

The lower end of the metal stent can be located inside the common bile duct above the major ampulla or in the duodenum through the major ampulla. These two procedures with supra- or trans-papillary stents are currently being performed in general clinical practices, depending on the preference of the endoscopists. Until now, the comparison of the clinical results of the two procedures has been scarcely studied, and there is no prospective study yet. Therefore, researchers aim to compare the clinical results of two stent procedures through prospective randomized controlled studies.

Detailed description: If surgical treatment is not possible in patients with malignant obstruction in the common bile duct, endoscopic metal stent placement to resolve biliary obstruction is a standard treatment that is commonly performed. The metal stents relieve the bile duct stenosis by malignant tumors, helping to drain the bile and improving jaundice. There is no doubt that the center of the metal stent is located in the central part of the biliary stricture, but the location of the lower end of the metal stent is not fixed. The lower end of the metal stent can be located in two main locations, either in the common bile duct above the major ampulla or in the duodenum through the major ampulla. These procedures with supra- or trans-papillary stents are performed in common and are determined by the operator's preference.

According to several retrospective studies so far, trans-papillary metal stents were effective in improving the initial biliary obstruction, but there was no difference in their long-term effects. Mao et al. showed that trans-papillary metal stents increase jaundice-free survival, and Shin et al. revealed the advantages of trans-papillary metal stents because they had a high success rate of secondary endoscopic procedures. On the contrary, Okamoto et al. showed that acute cholangitis more developed after trans-papillary metal stents placement, while Joe et al. revealed the advantages of supra-papillary metal stents because they reduce acute pancreatitis after the procedures. It has not yet been determined which method is effective. So far studies are all retrospective, and some of them placed the metal stents in a percutaneous way rather than endoscopy without sphincterotomy. Besides, some studies included intra-hepatic or hilar bile duct strictures, making it difficult to interpret the results.

Therefore, through a prospective randomized controlled study, the researchers want to compare the clinical results of supra- and trans-papillary metal stents placed by endoscopes in malignant common bile duct obstruction.

Eligibility criteria: Inclusion Criteria:

* patients with common bile duct obstruction due to malignancy

Exclusion Criteria:

* intrahepatic or perihilar bile duct obstruction (except Klatskin type I)
* patients who have operability or want surgery
* strictures located within 2 cm from the end of distal common bile duct
* patients who are not able to undergo endoscopy due to cardiovascular or pulmonary diseases
* patients whose informed consents are not received
* patients in whom an endoscope can not access to the ampulla due to anatomical deformity by previous surgery

Primary outcomes:
measure: Stent function maintenance duration
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: stone or sludge occurrence
timeFrame: through study completion, an average of 1 year
measure: in-stent stenosis or tumor overgrowth
timeFrame: through study completion, an average of 1 year
measure: acute cholangitis occurrence
timeFrame: through study completion, an average of 1 year
measure: stent migration rate
timeFrame: through study completion, an average of 1 year
measure: overall survival
timeFrame: From date of randomization until the date of date of death from any cause, assessed up to 36 months
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Jae Hyuck Chang
state: Kyunggi
Study officials:
References: