Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

NCT03921502 | Recruiting DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct; Obstruction, With Calculus; Choledocholithiasis

Keywords

Choledocholithiasis; Gall Bladder drainage; LAMS

Outcome Measures

Primary Outcomes (1)

• Number of paticipants readmitted due to biliary pathology

  Rate of participants readmitted due to biliary pathology (cholecystitis, cholangitis, pancreatitis, hepatic abscess...) in each group

  1 year

Secondary Outcomes (3)

• Number of participants with technical success

  1 day

• Number of dead participants

  1 year

• Hospital costs (euros)

  1 year

Study Arms (2)

ERCP with sphincterotomy + gall bladder drainage with LAMS

EXPERIMENTAL

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

ERCP with sphincterotomy

ACTIVE COMPARATOR

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

Interventions

Gall bladder transmural drainage with LAMS PROCEDURE

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.

ERCP with sphincterotomy; ERCP with sphincterotomy + gall bladder drainage with LAMS

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Age\>75 years

You may not qualify if:

• Charlson comorbidity scale adjusted to age \<4.
• 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
• ERCP failed (inhability to dain common bile duct)

Sponsors & Collaborators

• Hospital del Rio Hortega: lead
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital General Universitario de Alicante: collaborator

Study Sites (1)

Hospital Rio Hortega

Valladolid, 47012, Spain

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Bites and Stings; Choledocholithiasis

Interventions

laminin beta2

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Officials

• Ana Y Carbajo López, MD

  Hospital Río Hortega

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina de Benito Sanz, MD

CONTACT

983420400; mbenitosa@saludcastillayleon.es

Manuel Pérez-Miranda Castillo, MD, PhD

CONTACT

983420400; mperezmiranda@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multicentric double-blind randomized trial

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 19, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)