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Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy

Primary Purpose

Choledocholithiasis, Bile Duct Neoplasms, Biliary Tract Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a previous R-Y reconstruction
  • Clinical and radiological diagnosis of biliary obstruction

Exclusion Criteria:

  • Coagulopathy (International normalized ratio >1.5, platelet count <50,000)
  • Peritoneal carcinomatosis.

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group

Arm Description

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.

Outcomes

Primary Outcome Measures

Enteroscopy success rate
The proportion of patients with successful reaching and visualizing the papilla or biliopancreatic anastomosis using a short SBE among all patients

Secondary Outcome Measures

Therapeutic success rate
The proportion of patients with successful enteroscopic approch, biliopancreatic cannulation and therapeutic interventions using a short SBE among all patients

Full Information

First Posted
April 10, 2021
Last Updated
February 3, 2022
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04847167
Brief Title
Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy
Official Title
Mechanistic Loop Resolution Strategy for Short-type Single-balloon Enteroscopy-assisted Endoscopic Retrograde Cholangiopancreatography in Patients With Roux-en-Y Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Bile Duct Neoplasms, Biliary Tract Diseases, Roux-en-Y Anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enteroscopy success rate
Description
The proportion of patients with successful reaching and visualizing the papilla or biliopancreatic anastomosis using a short SBE among all patients
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Therapeutic success rate
Description
The proportion of patients with successful enteroscopic approch, biliopancreatic cannulation and therapeutic interventions using a short SBE among all patients
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a previous R-Y reconstruction Clinical and radiological diagnosis of biliary obstruction Exclusion Criteria: Coagulopathy (International normalized ratio >1.5, platelet count <50,000) Peritoneal carcinomatosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Jae Yang, MD, PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
443-380
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36136178
Citation
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. Erratum In: Surg Endosc. 2023 Aug 28;:
Results Reference
derived

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Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy

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