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Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage (LAMSCYL)

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ClinicalTrials.gov Identifier: NCT03921502
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Hospital Universitario Ramon y Cajal
Hospital General Universitario de Alicante
Information provided by (Responsible Party):
Marina de Benito Sanz, Hospital del Río Hortega

Brief Summary:

Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence.

The investigators propose a multicentric double-blind randomized trial. Our primary objective is to assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Also the investigators will analyze the proportion of technical success and complications.

The study population includes all patients older than 75 years with symptomatic choledocholithiasis. An estimated 75 subjects per group (ERCP alone and ERCP and transmural drainage) are needed.


Condition or disease Intervention/treatment Phase
Bile Duct; Obstruction, With Calculus Choledocholithiasis Procedure: Gall bladder transmural drainage with LAMS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentric double-blind randomized trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The patient and the physician responsible for the follow-up will be blinded as to the procedure performed (it will not be specified if transmural drainage was performed in the endoscopic report, nor will images of the drainage be included in the discharge report available in the electronic medical record until after the completion of the study or if complications are suspected).
Primary Purpose: Treatment
Official Title: Randomized Multicentre Double-blind Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage in Non-surgical Patients With Symptomatic Choledocholithiasis
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: ERCP with sphincterotomy + gall bladder drainage with LAMS
An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist. After this, transmural drainage of the gallbladder will be performed by placing a LAMS Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL will be placed on it to generate the anastomosis between the aforementioned structures.
Procedure: Gall bladder transmural drainage with LAMS
Placing a PAL Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL 15x10 mm or 10x10 mm will be *placed on it to generate the anastomosis between the aforementioned structures.

Active Comparator: ERCP with sphincterotomy
An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist.
Procedure: Gall bladder transmural drainage with LAMS
Placing a PAL Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL 15x10 mm or 10x10 mm will be *placed on it to generate the anastomosis between the aforementioned structures.




Primary Outcome Measures :
  1. Number of paticipants readmitted due to biliary pathology [ Time Frame: 1 year ]
    Rate of participants readmitted due to biliary pathology (cholecystitis, cholangitis, pancreatitis, hepatic abscess...) in each group


Secondary Outcome Measures :
  1. Number of participants with technical success [ Time Frame: 1 day ]
    Number of participants with correct placement of the stent from the gastric or duodenal lumen to the gallbladder, together with the documentation of bile flow and / or contrast through it.

  2. Number of dead participants [ Time Frame: 1 year ]
    Rate of deaths in each group

  3. Hospital costs (euros) [ Time Frame: 1 year ]
    Hospital costs (euros) during the period of follow up, including the baseline admission



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically or highly suspected by clinical data (acute cholangitis or obstructive jaundice), analytical and imaging according to the criteria of high probability of choledocholithiasis established in the clinical guidelines (ASGE Guide).
  • Discarded for surgical treatment due to age, comorbidity or refusal of the patient.

Exclusion Criteria:

  • Charlson comorbidity scale adjusted to age <4.
  • Prior ERCP.
  • Previous episodes of cholangitis, pancreatitis or lithiasic cholecystitis.
  • Hepatobiliary surgery or previous superior digestive tract.
  • Ascitis.
  • Inability to tolerate sedation of endoscopy, perforation of the digestive tract or other contraindication to endoscopy.
  • Coagulopathy with INR (international normalized ratio) > 1.5 not correctable or thrombocytopenia <50000 / mm3 not correctable.
  • Other diagnoses at admission (acute cholecystitis, acute pancreatitis, biliopancreatic neoplasia).
  • Hemodynamic instability.
  • Urgent procedure performed after hours
  • No availability of expert material / endoscopist in drainage.
  • Anatomical impossibility of performing biliary drainage (absence of vesicular distension, contact between gallbladder and stomach or duodenum, contact area <10 mm).
  • Baseline ECOG (Easthern Cooperative Oncology Group) > = 4
  • Expectancy of survival <6 months.
  • Refusal to participate.
  • Distance between the gallbladder and upper digestive tract> 1cm, scleroatrophic vesicle, lack of stable acoustic window for drainage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921502


Contacts
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Contact: Marina de Benito Sanz, MD 983420400 ext 84326 mbenitosa@saludcastillayleon.es
Contact: Manuel Pérez-Miranda Castillo, MD, PhD 983420400 ext 84408 mperezmiranda@saludcastillayleon.es

Locations
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Spain
Hospital Rio Hortega Recruiting
Valladolid, Spain, 47012
Contact: Marina De Benito, MD         
Sponsors and Collaborators
Hospital del Río Hortega
Hospital Universitario Ramon y Cajal
Hospital General Universitario de Alicante
Investigators
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Principal Investigator: Ana Y Carbajo López, MD Hospital Río Hortega
  Study Documents (Full-Text)

Documents provided by Marina de Benito Sanz, Hospital del Río Hortega:

Publications:

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Responsible Party: Marina de Benito Sanz, Principal investigator, Hospital del Río Hortega
ClinicalTrials.gov Identifier: NCT03921502     History of Changes
Other Study ID Numbers: 002
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marina de Benito Sanz, Hospital del Río Hortega:
Choledocholithiasis
Gall Bladder drainage
LAMS
Additional relevant MeSH terms:
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Choledocholithiasis
Cholestasis
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis