Common Bile Duct GallstonesPhase 3SIDERODNCT01425177
Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones
A Phase 3 study testing Normal Saline Irrigation in people with Common Bile Duct Gallstones, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones. After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Bile Duct Gallstones
- What is being tested?
- Normal Saline Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients were treated with CBD stone removal during therapeutic ERCP after finding CBD stones with CT, ultrasound or MRCP.
- The patients were treated with CBD stone removal during diagnostic ERCP because of cholangitis or cholecystitis.
Who cannot join
- Hemodynamic instability
- Younger than 18
- Mental illness
- Received previous CBD stone removal
- Hemolytic anemia, IHD stone, parasites in hepatobiliary system
- Genetic, autoimmune, congenital biliary disorder
- Liver or biliary surgery except cholecystectomy
- Pancreatic cancer, cholangiocarcinoma, ampulla of vater cancer
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seoungnam, Gyeonggi-do, 463-707
Sang Eon Jang, M.D., +82-10-7479-6271, medimax2@naver.com
Sang Hyub Lee, M.D. Ph.D, +82-10-8708-6267, gidoctor@snubh.org
About this study
Official title: Effect of Saline Irrigation to Decrease Rate of Residual Common Bile Duct Stones
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones.
After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients.
Read more
Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence.
Small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones.
Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.
Read the detailed description
CBD stones are defined as the occurrence of stones in the bile ducts. CBD stone usually causes biliary pain and jaundice, whereas obstruction that develops gradually over several months may manifest initially as pruritus or jaundice alone.
Unlike stones in the gallbladder, CBD stones cause symptoms, tend to present as life-threatening complications such as cholangitis and acute pancreatitis. Given its propensity to result in these serious complications, choledocholithiasis warrants treatment in nearly all cases In 2010, guideline for the risk and treatment of choledocholithiasis was published. The most predictive variables seem to be cholangitis, a bilirubin level higher than 1.7 mg/dL, and a dilated CBD on US. The presence of 2 or more of these variables results in a high probability of a CBD stone. Advanced age (older than 55 years), elevation of a liver biochemical test result other than bilirubin, and pancreatitis are less robust predictors for choledocholithiasis.
There are various ways of non invasive imaging diagnosis of CBD stone. The sensitivity of transabdominal US and conventional computed tomography (CT) in the detection of biliary stones is variable, ranging from 20% to 80% and from 23% to 85%, respectively. MRCP had sensitivity 92-93%, specificity 97-98%. Although MRCP is most excellent in diagnosis, the sensitivity is reduced 33-71% at diagnosis of small stones(less than 5mm) An ERCP has traditionally been considered the evaluation of biliary-tract diseases. This modality is very sensitive (90%) and specific (98%) in detecting CBD stone. EUS for the diagnosis of CBD stone reports widely varying sensitivities of 71% to 100% and specificities of 67% to 100%. Some papers report that intraductal ultrasound(IDUS) is very sensitive(97-100%). However, this is expensive and requires the fully-experienced endoscopist, so, it is difficult to use that.
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones. After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients.
Retained stone is defined as incomplete stone removal during ERCP, otherwise recurrent stone is defined as recurrence stone after complete stone removal. A criterion to distinguish between the two is stones rediscovery time after ERCP stone removal. Typically, bile duct stones found 6 months or more after endoscopic retrograde cholangiopancreatography (ERCP) generally are considered recurrent, as opposed to retained Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence.
For this reason, many studies that reduce the residual and recurrence CBD stones have been performed. Before procedures, MRCP, CT and EUS are performed to identify the exact location of stones. Many studies demonstrated that residual stone clearance with ENBD, EUS or IDUS immediately after ERCP stone removal are useful in reducing the recurrence.
However, cholangiogram with ENBD or using EUS after ERCP stone removal increases the duration of hospital stay, cost and the patient's discomfort. Until now, non-invasive, time reduced, cheap and simply way was unknown.
Recently, two different studies were published. Using IDUS could effectively find residual CBD stones that persisted after EST and balloon and basket extraction. Furthermore, normal saline irrigation of CBD after stone removal appeared useful in clearing residual small stones. These procedures could reduce the retained and recurrent stone Another study showed that additional IDUS to confirm complete stone clearance after ERCP with basket stone removal significantly decreases the early recurrence rate of common bile duct stones.
These studies demonstrated that small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones .
However, prospective study that saline irrigation without EUS or IDUS can reduce recurrent CBD stones after ERCP stone removal does not yet. Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.
- Conditions
- Common Bile Duct Gallstones
- Being tested
- Normal Saline Irrigation
- Keywords
- Retained CBD Stones, Recurrent CBD Stones
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline IrrigationProcedure or surgery
After removing CBD stones with the ERCP, 200ml of the normal saline solution was irrigated into the common bile duct.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline irrigation | Experimental | Not described Receives: Procedure: Normal Saline Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retained CBD stones
- CT or USG
- Symptomatic choledocholithiasis
Measured: From 3 to 6 months after procedure
Secondary outcomes (2)
Recurrent CBD Stones
- CT, USG
- Symptomatic choledocholithiasis
Measured: Over 6months after procedure
Cholangitis
- Fever, RUQ pain, Jaundice
Measured: Over 6months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct GallstonesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
- Investigators
- Sang Hyub Lee, M.D. Ph.D, Study director, Department of Internal Medicine, Seoul National University Bundang HospitalSang Eon Jang, M.D., Principal investigator, Department of Internal Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425177
- Sponsor's protocol ID
- LSH 0909
- Acronym
- SIDEROD
- Status last verified
- Aug 2011
- First submitted
- 26 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
PubMed 20105473Einstein DM, Lapin SA, Ralls PW, Halls JM. The insensitivity of sonography in the detection of choledocholithiasis. AJR Am J Roentgenol. 1984 Apr;142(4):725-8. doi: 10.2214/ajr.142.4.725.
PubMed 6608231Miller FH, Hwang CM, Gabriel H, Goodhartz LA, Omar AJ, Parsons WG 3rd. Contrast-enhanced helical CT of choledocholithiasis. AJR Am J Roentgenol. 2003 Jul;181(1):125-30. doi: 10.2214/ajr.181.1.1810125. No abstract available.
PubMed 12818842Soto JA, Alvarez O, Munera F, Velez SM, Valencia J, Ramirez N. Diagnosing bile duct stones: comparison of unenhanced helical CT, oral contrast-enhanced CT cholangiography, and MR cholangiography. AJR Am J Roentgenol. 2000 Oct;175(4):1127-34. doi: 10.2214/ajr.175.4.1751127.
PubMed 11000177Boraschi P, Neri E, Braccini G, Gigoni R, Caramella D, Perri G, Bartolozzi C. Choledocolithiasis: diagnostic accuracy of MR cholangiopancreatography. Three-year experience. Magn Reson Imaging. 1999 Nov;17(9):1245-53. doi: 10.1016/s0730-725x(99)00075-2.
PubMed 10576709Tse F, Liu L, Barkun AN, Armstrong D, Moayyedi P. EUS: a meta-analysis of test performance in suspected choledocholithiasis. Gastrointest Endosc. 2008 Feb;67(2):235-44. doi: 10.1016/j.gie.2007.09.047.
PubMed 18226685Das A, Isenberg G, Wong RC, Sivak MV Jr, Chak A. Wire-guided intraductal US: an adjunct to ERCP in the management of bile duct stones. Gastrointest Endosc. 2001 Jul;54(1):31-6. doi: 10.1067/mge.2001.115006.
PubMed 11427838Tseng LJ, Jao YT, Mo LR, Lin RC. Over-the-wire US catheter probe as an adjunct to ERCP in the detection of choledocholithiasis. Gastrointest Endosc. 2001 Dec;54(6):720-3. doi: 10.1067/mge.2001.119255.
PubMed 11726847Cotton PB, Geenen JE, Sherman S, Cunningham JT, Howell DA, Carr-Locke DL, Nickl NJ, Hawes RH, Lehman GA, Ferrari A, Slivka A, Lichtenstein DR, Baillie J, Jowell PS, Lail LM, Evangelou H, Bosco JJ, Hanson BL, Hoffman BJ, Rahaman SM, Male R. Endoscopic sphincterotomy for stones by experts is safe, even in younger patients with normal ducts. Ann Surg. 1998 Feb;227(2):201-4. doi: 10.1097/00000658-199802000-00008.
PubMed 9488517Duensing RA, Williams RA, Collins JC, Wilson SE. Managing choledocholithiasis in the laparoscopic era. Am J Surg. 1995 Dec;170(6):619-23. doi: 10.1016/s0002-9610(99)80028-2.
PubMed 7492013Keizman D, Shalom MI, Konikoff FM. An angulated common bile duct predisposes to recurrent symptomatic bile duct stones after endoscopic stone extraction. Surg Endosc. 2006 Oct;20(10):1594-9. doi: 10.1007/s00464-005-0656-x. Epub 2006 Jul 20.
PubMed 16858527Cheon YK, Lehman GA. Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. doi: 10.1097/00042737-200605000-00001.
PubMed 16607138Ando T, Tsuyuguchi T, Okugawa T, Saito M, Ishihara T, Yamaguchi T, Saisho H. Risk factors for recurrent bile duct stones after endoscopic papillotomy. Gut. 2003 Jan;52(1):116-21. doi: 10.1136/gut.52.1.116.
PubMed 12477771Tsuchiya S, Tsuyuguchi T, Sakai Y, Sugiyama H, Miyagawa K, Fukuda Y, Ando T, Saisho H, Yokosuka O. Clinical utility of intraductal US to decrease early recurrence rate of common bile duct stones after endoscopic papillotomy. J Gastroenterol Hepatol. 2008 Oct;23(10):1590-5. doi: 10.1111/j.1440-1746.2008.05458.x. Epub 2008 Jun 12.
PubMed 18554235Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.
PubMed 19249039
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Saline Irrigation to Decrease Rate of Residual Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT01425177
- Acronym / sponsor ID
- SIDEROD / LSH 0909
- Conditions
- Common Bile Duct Gallstones
- Keywords
- Retained CBD Stones, Recurrent CBD Stones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Aug 2011 (estimated)
- 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.
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones.
After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients.
Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence.
Small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones.
Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.
Detailed description
CBD stones are defined as the occurrence of stones in the bile ducts. CBD stone usually causes biliary pain and jaundice, whereas obstruction that develops gradually over several months may manifest initially as pruritus or jaundice alone.
Unlike stones in the gallbladder, CBD stones cause symptoms, tend to present as life-threatening complications such as cholangitis and acute pancreatitis. Given its propensity to result in these serious complications, choledocholithiasis warrants treatment in nearly all cases In 2010, guideline for the risk and treatment of choledocholithiasis was published. The most predictive variables seem to be cholangitis, a bilirubin level higher than 1.7 mg/dL, and a dilated CBD on US. The presence of 2 or more of these variables results in a high probability of a CBD stone. Advanced age (older than 55 years), elevation of a liver biochemical test result other than bilirubin, and pancreatitis are less robust predictors for choledocholithiasis.
There are various ways of non invasive imaging diagnosis of CBD stone. The sensitivity of transabdominal US and conventional computed tomography (CT) in the detection of biliary stones is variable, ranging from 20% to 80% and from 23% to 85%, respectively. MRCP had sensitivity 92-93%, specificity 97-98%. Although MRCP is most excellent in diagnosis, the sensitivity is reduced 33-71% at diagnosis of small stones(less than 5mm) An ERCP has traditionally been considered the evaluation of biliary-tract diseases. This modality is very sensitive (90%) and specific (98%) in detecting CBD stone. EUS for the diagnosis of CBD stone reports widely varying sensitivities of 71% to 100% and specificities of 67% to 100%. Some papers report that intraductal ultrasound(IDUS) is very sensitive(97-100%). However, this is expensive and requires the fully-experienced endoscopist, so, it is difficult to use that.
In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for the removal of bile duct stones. After procedures, there are some complications such as stone recurrence, papillary stenosis, cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite increasing experience and success with the procedure, occur in 4% to 24% of patients.
Retained stone is defined as incomplete stone removal during ERCP, otherwise recurrent stone is defined as recurrence stone after complete stone removal. A criterion to distinguish between the two is stones rediscovery time after ERCP stone removal. Typically, bile duct stones found 6 months or more after endoscopic retrograde cholangiopancreatography (ERCP) generally are considered recurrent, as opposed to retained Gallbladder stone, pneumobilia and many other various factors are known to be associated with CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It is natural that small stone fragments left after lithotripsy may act as nidi for stone recurrence.
For this reason, many studies that reduce the residual and recurrence CBD stones have been performed. Before procedures, MRCP, CT and EUS are performed to identify the exact location of stones. Many studies demonstrated that residual stone clearance with ENBD, EUS or IDUS immediately after ERCP stone removal are useful in reducing the recurrence.
However, cholangiogram with ENBD or using EUS after ERCP stone removal increases the duration of hospital stay, cost and the patient's discomfort. Until now, non-invasive, time reduced, cheap and simply way was unknown.
Recently, two different studies were published. Using IDUS could effectively find residual CBD stones that persisted after EST and balloon and basket extraction. Furthermore, normal saline irrigation of CBD after stone removal appeared useful in clearing residual small stones. These procedures could reduce the retained and recurrent stone Another study showed that additional IDUS to confirm complete stone clearance after ERCP with basket stone removal significantly decreases the early recurrence rate of common bile duct stones.
These studies demonstrated that small remaining stone could not be completely detected only using ERCP stone removal and remaining stone removal can reduce residual and recurrent stones. Saline irrigation was effective immediately after ERCP stone removal to remove remaining small stones .
However, prospective study that saline irrigation without EUS or IDUS can reduce recurrent CBD stones after ERCP stone removal does not yet. Saline irrigation has many advantages such as easy to treatment during ERCP stone removal, almost no additional cost and rare side effect. This study The authors expect this study is a remarkable role of ERCP stone removal procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal saline irrigation | Experimental | Procedure: Normal Saline Irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients were treated with CBD stone removal during therapeutic ERCP after finding CBD stones with CT, ultrasound or MRCP.
- The patients were treated with CBD stone removal during diagnostic ERCP because of cholangitis or cholecystitis.
Key exclusion criteria (8 listed)
- Hemodynamic instability
- Younger than 18
- Mental illness
- Received previous CBD stone removal
- Hemolytic anemia, IHD stone, parasites in hepatobiliary system
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 |
|---|---|---|
| Normal Saline IrrigationAfter removing CBD stones with the ERCP, 200ml of the normal saline solution was irrigated into the common bile duct. | Procedure or surgery | Normal saline irrigation |
Primary outcome
Retained CBD stones
Time frame: From 3 to 6 months after procedure
* CT or USG * Symptomatic choledocholithiasis
2 secondary outcomes
Recurrent CBD Stones
Time frame: Over 6months after procedure
Cholangitis
Time frame: Over 6months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Background: PubMed 20105473ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
- Background: PubMed 6608231Einstein DM, Lapin SA, Ralls PW, Halls JM. The insensitivity of sonography in the detection of choledocholithiasis. AJR Am J Roentgenol. 1984 Apr;142(4):725-8. doi: 10.2214/ajr.142.4.725.
- Background: PubMed 12818842Miller FH, Hwang CM, Gabriel H, Goodhartz LA, Omar AJ, Parsons WG 3rd. Contrast-enhanced helical CT of choledocholithiasis. AJR Am J Roentgenol. 2003 Jul;181(1):125-30. doi: 10.2214/ajr.181.1.1810125. No abstract available.
- Background: PubMed 11000177Soto JA, Alvarez O, Munera F, Velez SM, Valencia J, Ramirez N. Diagnosing bile duct stones: comparison of unenhanced helical CT, oral contrast-enhanced CT cholangiography, and MR cholangiography. AJR Am J Roentgenol. 2000 Oct;175(4):1127-34. doi: 10.2214/ajr.175.4.1751127.
- Background: PubMed 10576709Boraschi P, Neri E, Braccini G, Gigoni R, Caramella D, Perri G, Bartolozzi C. Choledocolithiasis: diagnostic accuracy of MR cholangiopancreatography. Three-year experience. Magn Reson Imaging. 1999 Nov;17(9):1245-53. doi: 10.1016/s0730-725x(99)00075-2.
- Background: PubMed 18226685Tse F, Liu L, Barkun AN, Armstrong D, Moayyedi P. EUS: a meta-analysis of test performance in suspected choledocholithiasis. Gastrointest Endosc. 2008 Feb;67(2):235-44. doi: 10.1016/j.gie.2007.09.047.
- Background: PubMed 11427838Das A, Isenberg G, Wong RC, Sivak MV Jr, Chak A. Wire-guided intraductal US: an adjunct to ERCP in the management of bile duct stones. Gastrointest Endosc. 2001 Jul;54(1):31-6. doi: 10.1067/mge.2001.115006.
- Background: PubMed 11726847Tseng LJ, Jao YT, Mo LR, Lin RC. Over-the-wire US catheter probe as an adjunct to ERCP in the detection of choledocholithiasis. Gastrointest Endosc. 2001 Dec;54(6):720-3. doi: 10.1067/mge.2001.119255.
- Background: PubMed 9488517Cotton PB, Geenen JE, Sherman S, Cunningham JT, Howell DA, Carr-Locke DL, Nickl NJ, Hawes RH, Lehman GA, Ferrari A, Slivka A, Lichtenstein DR, Baillie J, Jowell PS, Lail LM, Evangelou H, Bosco JJ, Hanson BL, Hoffman BJ, Rahaman SM, Male R. Endoscopic sphincterotomy for stones by experts is safe, even in younger patients with normal ducts. Ann Surg. 1998 Feb;227(2):201-4. doi: 10.1097/00000658-199802000-00008.
- Background: PubMed 7492013Duensing RA, Williams RA, Collins JC, Wilson SE. Managing choledocholithiasis in the laparoscopic era. Am J Surg. 1995 Dec;170(6):619-23. doi: 10.1016/s0002-9610(99)80028-2.
- Background: PubMed 16858527Keizman D, Shalom MI, Konikoff FM. An angulated common bile duct predisposes to recurrent symptomatic bile duct stones after endoscopic stone extraction. Surg Endosc. 2006 Oct;20(10):1594-9. doi: 10.1007/s00464-005-0656-x. Epub 2006 Jul 20.
- Background: PubMed 16607138Cheon YK, Lehman GA. Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. doi: 10.1097/00042737-200605000-00001.
- Seoul National University Bundang HospitalLink provided by the sponsor.
- Seoul National University College of MedicineLink provided by the sponsor.
- Korea Food and Drug AdministrationLink provided by the sponsor.
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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.
Sang Hyub Lee, M.D. Ph.D study director
Department of Internal Medicine, Seoul National University Bundang Hospital
Sang Eon Jang, M.D. principal investigator
Department of Internal Medicine, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline Irrigation in people with Common Bile Duct Gallstones, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 8 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 29 Aug 2011. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sang Eon Jang, M.D (+82-10-7479-6271, medimax2@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retained CBD stones (time frame: From 3 to 6 months after procedure). 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 NCT01425177, which also lists 17 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 29 Aug 2011.