NCT03103139

Brief Summary

  1. 1.Biliary duct injury are a relatively frequent complication of hepatobiliary surgery, most comonly laparoscopic cholecystecomy.
  2. 2.Prior to the development of more sophisticated endoscopic interventions, repeat surgery was often necessary for the management of biliary leaks.
  3. 3.Advances in technique and technology in gastroenterology endoscopy have largely replaced surgery as the first line intervention for biliary leak.
  4. 4.Most practices utilize endoscopic plastic biliary stent placement alone and are efficacious and equivalent to the biliary stent placement with endoscopic biliary sphincterotomy.
  5. 5.An area of variation is in whether biliary stent should cross the papilla ( with a shorter stent) versus the site of the bile leak (with a longer stent).
  6. 6.Our objective is to assess whether placing a biliary stent across the leak versus across the papilla alone improves the treatment of biliary leaks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

6.9 years

First QC Date

December 7, 2016

Last Update Submit

September 17, 2023

Conditions

Bile Leak

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with resolution of bile leak by cholangiography

    The primary outcome is the proportion of patients with resolution of bile leak determined by cholangiography at 5 weeks among the two groups.

    within 5 weeks

Secondary Outcomes (2)

  • Time to from ERCP to remove surgical drain

    within 5 weeks

  • Proportion of patients who required surgery

    within 10 weeks

Study Arms (2)

Transpapillary Stents

ACTIVE COMPARATOR

Stent placement across the Papilla (with a short plastic stent) for biliary leak

Procedure: Transpapillary Stent

Stent across bile leak

EXPERIMENTAL

Stent placement across the bile leak (with a longer stent) for biliary leak

Procedure: Stent across bile leak

Interventions

Transpapillary StentPROCEDURE

ERCP with placement of short stent

Transpapillary Stents
Stent across bile leakPROCEDURE

ERCP with long stent

Stent across bile leak

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bile leaks are suspected based on the following:
  • A) Persistent, significant drainage of bilious fluid from post-surgical drains following hepatobiliary surgery or cholecystectomy,.
  • B) Compatible symptoms plus imaging findings on abdominal ultrasonography, computed tomography, HIDA scanning, or MRCP of an abnormal intra-abdominal fluid collection in the setting of recent hepatobiliary surgery.

You may not qualify if:

  • Patients with bile duct transection (in which the duct has been totally severed into 2 parts) will be excluded as these are known to not be amenable to endoscopic therapy. Further, suspected bile leaks of non-surgical etiology will be excluded from the study (malignancy, trauma, spontaneous perforation, and other rarer causes). Bile leaks suspected two weeks post surgery will also not be included. Additionally patients who are pregnant, imprisoned, under age 18, unable to give informed consent, or have undergone prior biliary diversion surgery will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (9)

  • Buanes T, Waage A, Mjaland O, Solheim K. Bile leak after cholecystectomy significance and treatment: results from the National Norwegian Cholecystectomy Registry. Int Surg. 1996 Jul-Sep;81(3):276-9.

    PMID: 9028989RESULT

  • Rossi RL, Schirmer WJ, Braasch JW, Sanders LB, Munson JL. Laparoscopic bile duct injuries. Risk factors, recognition, and repair. Arch Surg. 1992 May;127(5):596-601; discussion 601-2. doi: 10.1001/archsurg.1992.01420050124016.

    PMID: 1533509RESULT

  • Barkun AN, Rezieg M, Mehta SN, Pavone E, Landry S, Barkun JS, Fried GM, Bret P, Cohen A. Postcholecystectomy biliary leaks in the laparoscopic era: risk factors, presentation, and management. McGill Gallstone Treatment Group. Gastrointest Endosc. 1997 Mar;45(3):277-82. doi: 10.1016/s0016-5107(97)70270-0.

    PMID: 9087834RESULT

  • Davids PH, Ringers J, Rauws EA, de Wit LT, Huibregtse K, van der Heyde MN, Tytgat GN. Bile duct injury after laparoscopic cholecystectomy: the value of endoscopic retrograde cholangiopancreatography. Gut. 1993 Sep;34(9):1250-4. doi: 10.1136/gut.34.9.1250.

    PMID: 8406163RESULT

  • Fasoulas K, Zavos C, Chatzimavroudis G, Trakateli C, Vasiliadis T, Ioannidis A, Kountouras J, Katsinelos P. Eleven-year experience on the endoscopic treatment of post-cholecystectomy bile leaks. Ann Gastroenterol. 2011;24(3):200-205.

    PMID: 24713781RESULT

  • Bjorkman DJ, Carr-Locke DL, Lichtenstein DR, Ferrari AP, Slivka A, Van Dam J, Brooks DC. Postsurgical bile leaks: endoscopic obliteration of the transpapillary pressure gradient is enough. Am J Gastroenterol. 1995 Dec;90(12):2128-33.

    PMID: 8540501RESULT

  • Mavrogiannis C, Liatsos C, Papanikolaou IS, Karagiannis S, Galanis P, Romanos A. Biliary stenting alone versus biliary stenting plus sphincterotomy for the treatment of post-laparoscopic cholecystectomy biliary leaks: a prospective randomized study. Eur J Gastroenterol Hepatol. 2006 Apr;18(4):405-9. doi: 10.1097/00042737-200604000-00014.

    PMID: 16538112RESULT

  • Katsinelos P, Kountouras J, Paroutoglou G, Chatzimavroudis G, Germanidis G, Zavos C, Pilpilidis I, Paikos D, Papaziogas B. A comparative study of 10-Fr vs. 7-Fr straight plastic stents in the treatment of postcholecystectomy bile leak. Surg Endosc. 2008 Jan;22(1):101-6. doi: 10.1007/s00464-007-9381-y. Epub 2007 May 22.

    PMID: 17516115RESULT

  • Nawaz H, Papachristou GI. Endoscopic treatment for post-cholecystectomy bile leaks: update and recent advances. Ann Gastroenterol. 2011;24(3):161-163. No abstract available.

    PMID: 24713786RESULT

Study Officials

  • James Buxbaum, M.D.

    USC Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2016

First Posted

April 6, 2017

Study Start

November 1, 2016

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)