Recurrent Common Bile Duct StonesNCT06601387
Evaluation of Choledochoduodonostomy vs Hepaticojejunostomy in Paients With Choledocholithiasis Indicated for Shunt.
A study testing choledochoduodonostomy and hepaticojejunostomy in people with Recurrent Common Bile Duct Stones, run by Mohamed Ahmed Hassan Aly at 1 site in Egypt.
Trial summary
A biliary-enteric anastomosis can be needed for a number of indications, including malignant or pre-malignant biliary diseases, benign biliary stenosis, bile duct injury, and complex choledocholithiasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Common Bile Duct Stones
- What is being tested?
- choledochoduodonostomy and hepaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- residual stones. recurrent stones, failed ERCP due to imacted large stone, Multiple CBD calculi with distal narrowing (Funnel syndrome), Papillary stenosis; impacted calculi, Biliary sludge-symptomatic, Sphincter of Oddi dysfunction/stenosis, Primary CBD stones; previous choledochotomy and Marked CBD dilatation.
Who cannot join
- surgically unfit patients, malignancy, infections e.g, cholangitis and coagulation disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Patients With Choledocholithiasis Indicated for Shunt .
A biliary-enteric anastomosis can be needed for a number of indications, including malignant or pre-malignant biliary diseases, benign biliary stenosis, bile duct injury, and complex choledocholithiasis. Choledochoduodenostomy is the most simple form of biliary-digestive anastomosis, with only minimal alteration to the normal anatomy. Due to the reported specific complications of choledochoduodenostomy, such as sump syndrome and gastritis caused by biliary reflux, creation of a HJ was preferred in the past decades . A Roux-en-Y hepaticojejunostomy (HJ) does not cause sump syndrome and only rarely reflux gastritis, but the procedure is more extensive, requiring an additional jejuno-jejunostomy .Especially for patients with extensive intra-abdominal adhesions or with a history of small bowel resections, the creation of a Roux-en-Y limb might pose a problem. Some recent publications have concluded that CD leads to acceptable surgical outcome, with low reported incidences of sump syndrome and reflux gastritis. However, these studies do not make a direct comparison between CD and HJ. Especially comparisons of long-term outcomes between CD and HJ are lacking.
Read the detailed description
There are 2 options are available: Choledochoduodonostomy or Roux-en-Y choledochojejunostomy. Both can be accomplished via a laparoscopic approach; however, thereis no consensus to which is best due to a paucity of data comparing the techniques.
Choice of operation is largely left up to the individual surgeon. Athough performed infrequently for benign biliary disease, biliary bypass operations are fundamental for any surgeon and are considered a core operation by the American College of Surgeons for any general surgery resident. In our study we are going to describe in detail our technique and outcomes when used for choledocholethiasis.
- Conditions
- Recurrent Common Bile Duct Stones
- Being tested
- choledochoduodonostomy, hepaticojejunostomy
- Keywords
- Choledochoduodonostomy, Hepaticojejunostomy, Choledocholithiasis
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choledochoduodonostomyProcedure or surgery
surgical drainage procedures
hepaticojejunostomyProcedure or surgery
surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| group 1 of patients | Other | recurrent CBD Stones. Receives: Procedure: choledochoduodonostomy |
| group 2 of patients | Other | recurrent CBD stones Receives: Procedure: hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome measure
Abd pain according to pain score from 1 to 10. total billirubin more than 1.2 mg/dl. Fever (temperature more than 38° c)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Dec 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Common Bile Duct StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparative prospective study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ahmed Hassan Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ahmed Hassan Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601387
- Sponsor's protocol ID
- Surgery for common bile duct
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park CY, Choi SH, Kwon CI, Cho JH, Jang SI, Lee TH, Han JH, Jeong S, Ko KH. What is the better surgical treatment option for recurrent common bile duct stones? Ann Surg Treat Res. 2020 Dec;99(6):329-336. doi: 10.4174/astr.2020.99.6.329. Epub 2020 Nov 26.
PubMed 33304860Xia H, Zhang H, Xin X, Liang B, Yang T, Liu Y, Wang J, Meng X. Surgical Management of Recurrence of Primary Intrahepatic Bile Duct Stones. Can J Gastroenterol Hepatol. 2023 Jan 23;2023:5158580. doi: 10.1155/2023/5158580. eCollection 2023.
PubMed 36726399
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Patients With Choledocholithiasis Indicated for Shunt .
- ClinicalTrials.gov ID
- NCT06601387
- Acronym / sponsor ID
- Surgery for common bile duct
- Conditions
- Recurrent Common Bile Duct Stones
- Keywords
- Choledochoduodonostomy, Hepaticojejunostomy, Choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mohamed Ahmed Hassan AlyUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A biliary-enteric anastomosis can be needed for a number of indications, including malignant or pre-malignant biliary diseases, benign biliary stenosis, bile duct injury, and complex choledocholithiasis. Choledochoduodenostomy is the most simple form of biliary-digestive anastomosis, with only minimal alteration to the normal anatomy. Due to the reported specific complications of choledochoduodenostomy, such as sump syndrome and gastritis caused by biliary reflux, creation of a HJ was preferred in the past decades . A Roux-en-Y hepaticojejunostomy (HJ) does not cause sump syndrome and only rarely reflux gastritis, but the procedure is more extensive, requiring an additional jejuno-jejunostomy .Especially for patients with extensive intra-abdominal adhesions or with a history of small bowel resections, the creation of a Roux-en-Y limb might pose a problem. Some recent publications have concluded that CD leads to acceptable surgical outcome, with low reported incidences of sump syndrome and reflux gastritis. However, these studies do not make a direct comparison between CD and HJ. Especially comparisons of long-term outcomes between CD and HJ are lacking.
Detailed description
There are 2 options are available: Choledochoduodonostomy or Roux-en-Y choledochojejunostomy. Both can be accomplished via a laparoscopic approach; however, thereis no consensus to which is best due to a paucity of data comparing the techniques.
Choice of operation is largely left up to the individual surgeon. Athough performed infrequently for benign biliary disease, biliary bypass operations are fundamental for any surgeon and are considered a core operation by the American College of Surgeons for any general surgery resident. In our study we are going to describe in detail our technique and outcomes when used for choledocholethiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative prospective study
| Arm | Type | Receives |
|---|---|---|
| group 1 of patients | Other | Procedure: choledochoduodonostomyrecurrent CBD Stones. |
| group 2 of patients | Other | Procedure: hepaticojejunostomyrecurrent CBD stones |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- residual stones. recurrent stones, failed ERCP due to imacted large stone, Multiple CBD calculi with distal narrowing (Funnel syndrome), Papillary stenosis; impacted calculi, Biliary sludge-symptomatic, Sphincter of Oddi dysfunction/stenosis, Primary CBD stones; previous choledochotomy and Marked CBD dilatation.
Key exclusion criteria (1 listed)
- surgically unfit patients, malignancy, infections e.g, cholangitis and coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choledochoduodonostomysurgical drainage procedures | Procedure or surgery | group 1 of patients |
| hepaticojejunostomysurgical intervention | Procedure or surgery | group 2 of patients |
Primary outcome
primary outcome measure
Time frame: one year
Abd pain according to pain score from 1 to 10. total billirubin more than 1.2 mg/dl. Fever (temperature more than 38° c)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Results publication: PubMed 33304860Park CY, Choi SH, Kwon CI, Cho JH, Jang SI, Lee TH, Han JH, Jeong S, Ko KH. What is the better surgical treatment option for recurrent common bile duct stones? Ann Surg Treat Res. 2020 Dec;99(6):329-336. doi: 10.4174/astr.2020.99.6.329. Epub 2020 Nov 26.
- Results publication: PubMed 36726399Xia H, Zhang H, Xin X, Liang B, Yang T, Liu Y, Wang J, Meng X. Surgical Management of Recurrence of Primary Intrahepatic Bile Duct Stones. Can J Gastroenterol Hepatol. 2023 Jan 23;2023:5158580. doi: 10.1155/2023/5158580. eCollection 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing choledochoduodonostomy and hepaticojejunostomy in people with Recurrent Common Bile Duct Stones, run by Mohamed Ahmed Hassan Aly at 1 site in Egypt.
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 1 inclusion and 1 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 3 Dec 2024. 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 Egypt. 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 Mohamed Ahmed Hassan, assistant lecturer (+201023858185, mouhmed.ahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome measure (time frame: one year). 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 NCT06601387, which also lists 2 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 3 Dec 2024.