AzTrials
AzTrials

CholedocholithiasisNCT05542784

Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study

An observational study of Choledocholithiasis, run by Shenzhen Second People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study intends to explore the success rate and clinical efficacy of modified LERV in the treatment of patients with non-dilated common bile duct (internal diameter ≤10mm) through a non-randomized controlled clinical trial, and to clarify whether modified LERV can be used as the preferred routine treatment for… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Choledocholithiasis
What is being tested?
Modified LERV
How many people
90 participants
Where
1 siteChina
Study dates
1 Jun 2022to 1 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 18 to 85 years with common bile duct stones who are suitable for and consent to undergo laparoscopic plus endoscopic surgery under general anesthesia

Who may be able to join

  • 1、18 years ≤ age <85 years 2、clinical diagnosis of choledocholithiasis secondary to cholecystolithiasis and middle choledocholithiasis (MCBD) diameter ≤10mm; The diameter of MCBD was based on MRCP measurements. If MRCP could not be performed, CT images were used as reference, and B-ultrasound measurements were used as the standard.
  • 3、 Good cardiopulmonary function, anesthesia evaluation tolerance under general anesthesia laparoscopic + endoscopic surgery.
  • -

Who cannot join

  • 1、 Intrahepatic bile duct stones with indications for surgery, and need simultaneous surgery; 2、 Patients with choledocholithiasis >2 cm or a large number of stones were difficult to remove; 3、 Patients with malignant hepatobiliary and pancreatic tumors or biliary tract malformations; 4、 Severe patients with severe pancreatitis and septic shock before operation; 5、Patients with previous gastric and duodenoscopic surgery history and interruption of gastroduodenal continuity; 6、 Severe partial stenosis of the upper gastrointestinal tract (from the oral cavity to the second duodenum), which is expected to be inaccessible to the duodenoscope.
  • -

Trial locations and contacts

1 site in 1 country.

Yongqiang Zhan, Chief physician contact

13714096676

yqzhan@sina.com

China1 site, 1 recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

    Guohui Nie, dean

    Recruiting

Other trials in China

About this study

This study intends to explore the success rate and clinical efficacy of modified LERV in the treatment of patients with non-dilated common bile duct (internal diameter ≤10mm) through a non-randomized controlled clinical trial, and to clarify whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Read the detailed description

Patients with cholecystolithiasis secondary to common bile duct stones requiring surgical treatment during a 3-year period from 2022-6-1 to 2025-3-31 were enrolled in this non-randomized controlled clinical trial. Preoperative diameter of the middle common bile duct was determined by magnetic resonance cholangiography (MRCP) or B-ultrasound measurement. The actual treatment plan of the patients was recorded, including LERV treatment and ERCP+LC treatment. The baseline data and the success rate of stone removal, operation time, postoperative stone residual rate, complication rate, length of hospital stay and hospitalization cost were recorded for observation and follow-up. To determine whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Being tested
Modified LERV
Medical subject headings
Choledocholithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified LERVProcedure or surgery

    Also called Pre ERCP+LC

    Patients routinely underwent LC. The ligature clamp clamps the distal end of the capsule tube. In this case, you need to perform two steps:

    Laparoscopic operation: proximal incision, anterograde placement of guide wire into the duodenum. The catheter was removed and the balloon dilated. The balloon was released and removed when the ERCP was initiated for cannulation. After successful ERCP retrograde placement, the anterograde guide wire was pulled out and the gallbladder was removed.

    ERCP procedure: After the anterograde guide wire was observed by duodenoscope, duodenal papilla was placed through a retrograde incision along the anterograde guide wire, and a retrograde cannula was inserted into the common bile duct. Remove stones by dragging them with a net basket or/and balloon. Angiography confirmed that there was no filling defect in the extrahepatic bile duct, and ENBD was indwelled.

Study groups in NCT05542784
Study groupRoleWhat they receive
Patients with choledocholithiasis secondary to choledocholithiasis undergoing LERV surgeryNot described
Receives: Procedure: Modified LERV
Patients with choledocholithiasis secondary to choledocholithiasis undergoing PreERCP+LC surgeryNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness evaluation index

    Success rate of stone removal (as judged by ERCP imaging)

    Measured: intraoperative

Secondary outcomes (3)

  1. Postoperative related clinical indicators

    The incidence of PEP

    Measured: Blood routine, pancreatic enzyme binomial and liver function were examined on the first and second day after operation.

  2. The hospital indicators

    Length of hospital stay after operation (including operation day), hospitalization cost after operation (including operation day)

    Measured: an average 1 week

  3. the incidence of serious complications

    including duodenal papilla hemorrhage, duodenal perforation, acute pancreatitis, duodenal leakage (fistula), abdominal abscess, the incidence of hyperamylasemia, the incidence of residual common bile duct stones, etc.

    Measured: Within 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2022
  2. Study start1 Jun 2022
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05542784
Sponsor's protocol ID
20223357016
Status last verified
May 2022
First submitted
29 Jul 2022
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tazuma S. Gallstone disease: Epidemiology, pathogenesis, and classification of biliary stones (common bile duct and intrahepatic). Best Pract Res Clin Gastroenterol. 2006;20(6):1075-83. doi: 10.1016/j.bpg.2006.05.009.

    PubMed 17127189

  • Bradley A, Sami S, Hemadasa N, Macleod A, Brown LR, Apollos J. Decision analysis of minimally invasive management options for cholecysto-choledocholithiasis. Surg Endosc. 2020 Dec;34(12):5211-5222. doi: 10.1007/s00464-020-07816-w. Epub 2020 Jul 24.

    PubMed 32710213

  • Deslandres E, Gagner M, Pomp A, Rheault M, Leduc R, Clermont R, Gratton J, Bernard EJ. Intraoperative endoscopic sphincterotomy for common bile duct stones during laparoscopic cholecystectomy. Gastrointest Endosc. 1993 Jan-Feb;39(1):54-8. doi: 10.1016/s0016-5107(93)70011-5. No abstract available.

    PubMed 8454146

  • Liu W, Wang Q, Xiao J, Zhao L, Huang J, Tan Z, Li P. A modified technique reduced operative time of laparoendoscopic rendezvous endoscopic retrograde cholangiopancreatography combined with laparoscopic cholecystectomy for concomitant gallstone and common bile ductal stone. Gastroenterol Res Pract. 2014;2014:861295. doi: 10.1155/2014/861295. Epub 2014 Jun 15.

    PubMed 25024701

  • Mine T, Morizane T, Kawaguchi Y, Akashi R, Hanada K, Ito T, Kanno A, Kida M, Miyagawa H, Yamaguchi T, Mayumi T, Takeyama Y, Shimosegawa T. Clinical practice guideline for post-ERCP pancreatitis. J Gastroenterol. 2017 Sep;52(9):1013-1022. doi: 10.1007/s00535-017-1359-5. Epub 2017 Jun 26.

    PubMed 28653082

  • Bailey AA, Bourke MJ, Williams SJ, Walsh PR, Murray MA, Lee EY, Kwan V, Lynch PM. A prospective randomized trial of cannulation technique in ERCP: effects on technical success and post-ERCP pancreatitis. Endoscopy. 2008 Apr;40(4):296-301. doi: 10.1055/s-2007-995566.

    PubMed 18389448

  • Cotton PB, Garrow DA, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc. 2009 Jul;70(1):80-8. doi: 10.1016/j.gie.2008.10.039. Epub 2009 Mar 14.

    PubMed 19286178

  • ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.

    PubMed 30979521

  • Noel R, Enochsson L, Swahn F, Lohr M, Nilsson M, Permert J, Arnelo U. A 10-year study of rendezvous intraoperative endoscopic retrograde cholangiography during cholecystectomy and the risk of post-ERCP pancreatitis. Surg Endosc. 2013 Jul;27(7):2498-503. doi: 10.1007/s00464-012-2768-4. Epub 2013 Jan 26.

    PubMed 23355164

  • Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

    PubMed 31863440

  • Pan L, Chen M, Ji L, Zheng L, Yan P, Fang J, Zhang B, Cai X. The Safety and Efficacy of Laparoscopic Common Bile Duct Exploration Combined with Cholecystectomy for the Management of Cholecysto-choledocholithiasis: An Up-to-date Meta-analysis. Ann Surg. 2018 Aug;268(2):247-253. doi: 10.1097/SLA.0000000000002731.

    PubMed 29533266

  • Ricci C, Pagano N, Taffurelli G, Pacilio CA, Migliori M, Bazzoli F, Casadei R, Minni F. Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi: A Systematic Review and Network Meta-analysis. JAMA Surg. 2018 Jul 18;153(7):e181167. doi: 10.1001/jamasurg.2018.1167. Epub 2018 Jul 18.

    PubMed 29847616

  • Tan C, Ocampo O, Ong R, Tan KS. Comparison of one stage laparoscopic cholecystectomy combined with intra-operative endoscopic sphincterotomy versus two-stage pre-operative endoscopic sphincterotomy followed by laparoscopic cholecystectomy for the management of pre-operatively diagnosed patients with common bile duct stones: a meta-analysis. Surg Endosc. 2018 Feb;32(2):770-778. doi: 10.1007/s00464-017-5739-y. Epub 2017 Jul 21.

    PubMed 28733744

  • Tse F, Yuan Y, Moayyedi P, Leontiadis GI. Guide wire-assisted cannulation for the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis. Endoscopy. 2013 Aug;45(8):605-18. doi: 10.1055/s-0032-1326640. Epub 2013 Jun 27.

    PubMed 23807804

  • Morino M, Baracchi F, Miglietta C, Furlan N, Ragona R, Garbarini A. Preoperative endoscopic sphincterotomy versus laparoendoscopic rendezvous in patients with gallbladder and bile duct stones. Ann Surg. 2006 Dec;244(6):889-93; discussion 893-6. doi: 10.1097/01.sla.0000246913.74870.fc.

    PubMed 17122614

Questions about this trial

What is this clinical trial studying?

An observational study of Choledocholithiasis, run by Shenzhen Second People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongqiang Zhan, Chief physician (13714096676, yqzhan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness evaluation index (time frame: intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05542784, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in