CholedocholithiasisNCT04847167
Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy
A study testing Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group in people with Choledocholithiasis and Bile Duct Neoplasms, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is the current standard technique for the treatment of pancreatobiliary disease. However, ERCP in patients with a surgically altered anatomy (SAA) remains a challenge. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Choledocholithiasis, Bile Duct Neoplasms, Biliary Tract Diseases
- What is being tested?
- Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2020to 31 Dec 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a previous R-Y reconstruction
- Clinical and radiological diagnosis of biliary obstruction
Who cannot join
- Coagulopathy (International normalized ratio >1.5, platelet count <50,000)
- Peritoneal carcinomatosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanistic Loop Resolution Strategy for Short-type Single-balloon Enteroscopy-assisted Endoscopic Retrograde Cholangiopancreatography in Patients With Roux-en-Y Reconstruction
Endoscopic retrograde cholangiopancreatography (ERCP) is the current standard technique for the treatment of pancreatobiliary disease. However, ERCP in patients with a surgically altered anatomy (SAA) remains a challenge. The short-type balloon enteroscope dedicated to pancreatobiliary intervention was recently introduced and has gained popularity as a primary modality for ERCP in patients with SAA. The currently available short-type single-balloon enteroscope (SBE) has a 3.2-mm enlarged diameter for the working channel and a 152-cm shortened working length, which can accommodate most conventional ERCP accessories and stent assemblies, and it is equipped with high-force transmission and passive bending, which facilitate passing the sharply angulated bowel segment. However, Roux-en-Y (R-Y) reconstruction anatomy is still challenging for the pancreatobiliary physician with regard to ERCP owing to the long length of the Roux and pancreatobiliary limb, and bowel angulations around the jejunojejunal anastomosis. The pooled procedural success of short SBE-assisted ERCP (SBE-ERCP) for R-Y reconstruction was reported to be 76.4% in a recent metaanalysis.
The most important factor for procedural success and safety of short SBE-ERCP for R-Y patients is to resolve and prevent various bowel types looping through the collaborative manipulation of an enteroscope and overtube. In the clinical field, there is an unmet need for a formulaic loop-handing technique that can be applied to most cases of R-Y reconstruction. Therefore, in the current study, we aimed to evaluate the efficacy and safety of a mechanistic loop resolution strategy for short SBE-ERCP in patients undergoing R-Y reconstruction.
Read the detailed description
SBE-ERCP and mechanistic loop resolution strategy The mechanistic loop resolution strategy was first introduced by an experienced senior professor with 30 years of experience with conventional balloon enteroscopy and ERCP. Based on this strategy, SBE-ERCP in this study was performed by a junior professor with 8 years of experience in colonoscopy and ERCP and had performed 5 cases of conventional BE-ERCP as an assistant before 2019. The short SBE was introduced in Korea in 2019, and from this time, the junior professor underwent training in SBE-ERCP with the mechanistic loop resolution strategy via 10 cases with Billroth-II or R-Y anatomy. From January 2020, he began performing SBE-ERCP as the main operator.
All ERCP procedures were performed with the patient in the prone position using an SBE (SIF-H290S; Olympus Corp., Japan) under CO2 insufflation and conscious sedation. A soft transparent hood (D-201-11804; Olympus Corp.) was used in all cases. The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp.) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope by gently pulling the enteroscope, similar to the ERCP accessory advancement over the guidewire.
Mechanistic loop resolution strategy for total gastrectomy with R-Y reconstruction First (Step 1), an enteroscope was inserted beyond the esophagojejunal anastomosis into the jejunum, and the overtube was advanced across the esophagojejunal anastomosis to prevent recurrent reverse C-loop formation at the esophagojejunal junction. Second (Step 2), whenever an enteroscope was passed through the U-shaped or inverse U-shaped jejunal segment, an overtube was advanced along the enteroscope to sufficiently cover the U-shaped or inverse U-shaped jejunal segment. Thereafter, the enteroscope-overtube apparatus was retracted simultaneously after overtube ballooning to pleat the jejunum and to prevent U-loop or inverse U-loop reformation following subsequent enteroscope insertion. Subsequently (Step 3), when the U-shaped, inverse U loop became part of a three-dimensionally rotated N-loop, the enteroscope occasionally could not pass the U-shaped or inverse U-shaped jejunal segment, making a cane shape. At that time, the control section of the enteroscope was rotated 360° from its place, clockwise or counterclockwise toward the direction in which the loop formation was prevented. This preemptive extreme rotation maneuver aimed to minimize rotational vector forces from the loop and stiffen the enteroscope. Further (Step 4), when a three-dimensionally rotated loop containing a ring structure such as alpha, reverse alpha, and gamma loop was formed during enteroscope advance, before the trial of loop resolution, the tip of the overtube was positioned so that it did not reach the ring structure of the loop, with the ring structure not being covered with the overtube. Thereafter, the loop was corrected by rotating the enteroscope-overtube apparatus. This maneuver allowed the enteroscope to rotate in a three-dimensional spiral direction, whereas the overtube rotated in place, leading to the effective transmission of the rotational force generated by the operator's hand to the enteroscope-overtube apparatus. Biliopancreatic cannulation and therapeutic maneuvers were attempted by intentionally retroflexing the enteroscope tip near the inferior duodenal flexure. In Step 5, if the enteroscope tip was repetitively withdrawn before complete loop resolution due to a weak anchoring effect of the enteroscope tip, the overtube was further advanced into the ring structure of the loop to support the additional advancement of the enteroscope until a more suitable point for hooking and anchoring the enteroscope tip. When the enteroscope tip reached this anchoring point, the overtube was retracted back to the starting point of the ring structure of the loop, while maintaining the enteroscope tip in place. Thereafter, loop resolution was reattempted as described in Step 4. In Step 6, after passing the SBE into the pancreatobiliary jejunal limb and duodenum, a large reverse alpha loop that was formed through the Roux limb, jejunojejunal anastomosis, and pancreatobiliary limb was usually allowed without a trial of reduction because it facilitated the retroflex positioning of the enteroscope tip around the inferior duodenal flexure and guaranteed an enface view of the major papilla.
Mechanistic loop resolution strategy for R-Y hepaticojejunostomy with preserved stomach First (Step 1), once the enteroscope reached the second or third portion of the duodenum in a long-scope position, the enteroscope was straightened with rightward rotation and retraction, making a short-scope position, similar to the ERCP position. An overtube was passed into the duodenum over the straightened enteroscope, maintaining the short-scope position. The overtube balloon was positioned in the superior duodenal angle or duodenal bulb across the pyloric ring and inflated to prevent the overtube from being withdrawn back into the stomach. Thereafter (Step 2), the enteroscope was further advanced into the distal duodenum and jejunum, maintaining the short-scope position and being cautious of the recurrence of the long-scope position of the enteroscope in the stomach. In this step, continuous covering of the superior duodenal angle and pyloric ring with the overtube balloon was crucial for maintaining the short-scope position. In Step 3, after the tip of the enteroscope was inserted deep into the jejunum, the unstable loops over the superior and inferior duodenal flexure were corrected, making the esophagus, stomach, duodenum, and proximal jejunum lie in a straight line. The other basic loop resolution strategies were the same as those described for total gastrectomy with R-Y reconstruction.
- Being tested
- Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
- Medical subject headings
- Choledocholithiasis, Bile Duct Neoplasms, Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy groupProcedure or surgery
The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire.
| Study group | Role | What they receive |
|---|---|---|
| Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group | Experimental | All ERCP was performed with the patient in the prone position using a SBE (SIF-H290S; Olympus Corp., Japan) under CO2 insufflation and conscious sedation. A soft transparent hood (D-201-11804; Olympus Corp., Japan) was used in all cases. The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire. Receives: Procedure: Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteroscopy success rate
The proportion of patients with successful reaching and visualizing the papilla or biliopancreatic anastomosis using a short SBE among all patients
Measured: During procedure
Secondary outcomes (1)
Therapeutic success rate
The proportion of patients with successful enteroscopic approch, biliopancreatic cannulation and therapeutic interventions using a short SBE among all patients
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start24 Feb 2020
- Primary completion20 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Jae Yang, Ajou University School of Medicine
- Investigators
- Min Jae Yang, MD, PhD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847167
- Sponsor's protocol ID
- 20-611
- Status last verified
- Feb 2022
- First submitted
- 10 Apr 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang MJ, Kim JH, Hwang JC, Yoo BM, Park SW, Kwon CI, Jeong S. Mechanistic loop resolution strategy for short-type single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y reconstruction after gastrectomy (with video). Surg Endosc. 2022 Nov;36(11):8690-8696. doi: 10.1007/s00464-022-09575-2. Epub 2022 Sep 22.
PubMed 36136178
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Loop Resolution Strategy for Short-type Single-balloon Enteroscopy-assisted Endoscopic Retrograde Cholangiopancreatography in Patients With Roux-en-Y Reconstruction
- ClinicalTrials.gov ID
- NCT04847167
- Acronym / sponsor ID
- 20-611
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Apr 2021 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) is the current standard technique for the treatment of pancreatobiliary disease. However, ERCP in patients with a surgically altered anatomy (SAA) remains a challenge. The short-type balloon enteroscope dedicated to pancreatobiliary intervention was recently introduced and has gained popularity as a primary modality for ERCP in patients with SAA. The currently available short-type single-balloon enteroscope (SBE) has a 3.2-mm enlarged diameter for the working channel and a 152-cm shortened working length, which can accommodate most conventional ERCP accessories and stent assemblies, and it is equipped with high-force transmission and passive bending, which facilitate passing the sharply angulated bowel segment. However, Roux-en-Y (R-Y) reconstruction anatomy is still challenging for the pancreatobiliary physician with regard to ERCP owing to the long length of the Roux and pancreatobiliary limb, and bowel angulations around the jejunojejunal anastomosis. The pooled procedural success of short SBE-assisted ERCP (SBE-ERCP) for R-Y reconstruction was reported to be 76.4% in a recent metaanalysis.
The most important factor for procedural success and safety of short SBE-ERCP for R-Y patients is to resolve and prevent various bowel types looping through the collaborative manipulation of an enteroscope and overtube. In the clinical field, there is an unmet need for a formulaic loop-handing technique that can be applied to most cases of R-Y reconstruction. Therefore, in the current study, we aimed to evaluate the efficacy and safety of a mechanistic loop resolution strategy for short SBE-ERCP in patients undergoing R-Y reconstruction.
Detailed description
SBE-ERCP and mechanistic loop resolution strategy The mechanistic loop resolution strategy was first introduced by an experienced senior professor with 30 years of experience with conventional balloon enteroscopy and ERCP. Based on this strategy, SBE-ERCP in this study was performed by a junior professor with 8 years of experience in colonoscopy and ERCP and had performed 5 cases of conventional BE-ERCP as an assistant before 2019. The short SBE was introduced in Korea in 2019, and from this time, the junior professor underwent training in SBE-ERCP with the mechanistic loop resolution strategy via 10 cases with Billroth-II or R-Y anatomy. From January 2020, he began performing SBE-ERCP as the main operator.
All ERCP procedures were performed with the patient in the prone position using an SBE (SIF-H290S; Olympus Corp., Japan) under CO2 insufflation and conscious sedation. A soft transparent hood (D-201-11804; Olympus Corp.) was used in all cases. The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp.) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope by gently pulling the enteroscope, similar to the ERCP accessory advancement over the guidewire.
Mechanistic loop resolution strategy for total gastrectomy with R-Y reconstruction First (Step 1), an enteroscope was inserted beyond the esophagojejunal anastomosis into the jejunum, and the overtube was advanced across the esophagojejunal anastomosis to prevent recurrent reverse C-loop formation at the esophagojejunal junction. Second (Step 2), whenever an enteroscope was passed through the U-shaped or inverse U-shaped jejunal segment, an overtube was advanced along the enteroscope to sufficiently cover the U-shaped or inverse U-shaped jejunal segment. Thereafter, the enteroscope-overtube apparatus was retracted simultaneously after overtube ballooning to pleat the jejunum and to prevent U-loop or inverse U-loop reformation following subsequent enteroscope insertion. Subsequently (Step 3), when the U-shaped, inverse U loop became part of a three-dimensionally rotated N-loop, the enteroscope occasionally could not pass the U-shaped or inverse U-shaped jejunal segment, making a cane shape. At that time, the control section of the enteroscope was rotated 360° from its place, clockwise or counterclockwise toward the direction in which the loop formation was prevented. This preemptive extreme rotation maneuver aimed to minimize rotational vector forces from the loop and stiffen the enteroscope. Further (Step 4), when a three-dimensionally rotated loop containing a ring structure such as alpha, reverse alpha, and gamma loop was formed during enteroscope advance, before the trial of loop resolution, the tip of the overtube was positioned so that it did not reach the ring structure of the loop, with the ring structure not being covered with the overtube. Thereafter, the loop was corrected by rotating the enteroscope-overtube apparatus. This maneuver allowed the enteroscope to rotate in a three-dimensional spiral direction, whereas the overtube rotated in place, leading to the effective transmission of the rotational force generated by the operator's hand to the enteroscope-overtube apparatus. Biliopancreatic cannulation and therapeutic maneuvers were attempted by intentionally retroflexing the enteroscope tip near the inferior duodenal flexure. In Step 5, if the enteroscope tip was repetitively withdrawn before complete loop resolution due to a weak anchoring effect of the enteroscope tip, the overtube was further advanced into the ring structure of the loop to support the additional advancement of the enteroscope until a more suitable point for hooking and anchoring the enteroscope tip. When the enteroscope tip reached this anchoring point, the overtube was retracted back to the starting point of the ring structure of the loop, while maintaining the enteroscope tip in place. Thereafter, loop resolution was reattempted as described in Step 4. In Step 6, after passing the SBE into the pancreatobiliary jejunal limb and duodenum, a large reverse alpha loop that was formed through the Roux limb, jejunojejunal anastomosis, and pancreatobiliary limb was usually allowed without a trial of reduction because it facilitated the retroflex positioning of the enteroscope tip around the inferior duodenal flexure and guaranteed an enface view of the major papilla.
Mechanistic loop resolution strategy for R-Y hepaticojejunostomy with preserved stomach First (Step 1), once the enteroscope reached the second or third portion of the duodenum in a long-scope position, the enteroscope was straightened with rightward rotation and retraction, making a short-scope position, similar to the ERCP position. An overtube was passed into the duodenum over the straightened enteroscope, maintaining the short-scope position. The overtube balloon was positioned in the superior duodenal angle or duodenal bulb across the pyloric ring and inflated to prevent the overtube from being withdrawn back into the stomach. Thereafter (Step 2), the enteroscope was further advanced into the distal duodenum and jejunum, maintaining the short-scope position and being cautious of the recurrence of the long-scope position of the enteroscope in the stomach. In this step, continuous covering of the superior duodenal angle and pyloric ring with the overtube balloon was crucial for maintaining the short-scope position. In Step 3, after the tip of the enteroscope was inserted deep into the jejunum, the unstable loops over the superior and inferior duodenal flexure were corrected, making the esophagus, stomach, duodenum, and proximal jejunum lie in a straight line. The other basic loop resolution strategies were the same as those described for total gastrectomy with R-Y reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group | Experimental | Procedure: Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy groupAll ERCP was performed with the patient in the prone position using a SBE (SIF-H290S; Olympus Corp., Japan) under CO2 insufflation and conscious sedation. A soft transparent hood (D-201-11804; Olympus Corp., Japan) was used in all cases. The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a previous R-Y reconstruction
- Clinical and radiological diagnosis of biliary obstruction
Key exclusion criteria (2 listed)
- Coagulopathy (International normalized ratio >1.5, platelet count <50,000)
- Peritoneal carcinomatosis.
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 |
|---|---|---|
| Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy groupThe SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire. | Procedure or surgery | Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group |
Primary outcome
Enteroscopy success rate
Time frame: During procedure
The proportion of patients with successful reaching and visualizing the papilla or biliopancreatic anastomosis using a short SBE among all patients
1 secondary outcome
Therapeutic success rate
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 36136178Yang MJ, Kim JH, Hwang JC, Yoo BM, Park SW, Kwon CI, Jeong S. Mechanistic loop resolution strategy for short-type single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y reconstruction after gastrectomy (with video). Surg Endosc. 2022 Nov;36(11):8690-8696. doi: 10.1007/s00464-022-09575-2. Epub 2022 Sep 22.
- 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.
Min Jae Yang, MD, PhD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group in people with Choledocholithiasis and Bile Duct Neoplasms, run by Ajou University School of Medicine 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 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: finished, as of the sponsor's last update on 21 Feb 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteroscopy success rate (time frame: During 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 NCT04847167, which also lists 1 linked publication.
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 21 Feb 2022.