Clinical utility of novel ultrathin single-balloon enteroscopy: a feasibility study

• Abstract
• Introduction
• Methods
• Patients
• Single-balloon enteroscopy procedures
• Single-balloon system
• Results
• Discussion
• References

Abstract

Background The advent of balloon-assisted enteroscopy (BAE) has facilitated the examination of the entire digestive tract. However, using a rigid sliding tube during the procedure reduces patient acceptance. This study evaluated the clinical application of a newly developed ultrathin single-balloon enteroscope for BAE.

Methods 28 outpatients underwent enteroscopy with a novel ultrathin single-balloon enteroscope. None of the subjects required therapeutic procedures, such as balloon dilation or hemostasis. The insertability, efficacy, and safety of the ultrathin single-balloon endoscope were evaluated retrospectively.

Results 7 patients underwent transoral enteroscopy and 21 patients underwent transanal enteroscopy under conscious sedation. No adverse events related to the procedure were reported in any patients. Targeted observation and/or targeted biopsy were achieved in all procedures. All transoral procedures allowed evaluation of the jejunum beyond the ligament of Treitz. All transanal procedures allowed intubation of the terminal ileum, despite several patients having severe stenosis of the colon and ileum.

Conclusion A novel ultrathin single-balloon enteroscope showed adequate insertability and safety for outpatient surveillance enteroscopy under conscious sedation.

Introduction

Although double-balloon enteroscopy (DBE) [1] and single-balloon enteroscopy (SBE) [2] are established as useful tools for evaluating small-bowel disease [3], these balloon-assisted enteroscopy (BAE) procedures are invasive procedures requiring the patient to receive sedation or anesthesia, and patients undergoing BAE therefore need to be hospitalized to recover from deep sedation [4]. Furthermore, the use of a rigid sliding tube causes pain during the procedure, thereby reducing patient acceptance among patients in Japan, especially if they are under conscious sedation.

Several studies have reported that using a thin endoscope can reduce pain during screening esophagogastroduodenoscopy (EGD) and colonoscopy [5] [6], and using a thin endoscope for enteroscopy is also considered to reduce patient discomfort. A new ultrathin single-balloon enteroscope and sliding tube prototype have been developed by Olympus to overcome the issue of patient pain. However, the extreme flexibility of the ultrathin enteroscope is associated with poor operability and difficulty in manipulating it, for instance through the ileocecal valve and ligament of Treitz. This study therefore aimed to clarify the clinical usefulness of the newly developed ultrathin single-balloon enteroscope.

Methods

Patients

A total of 28 patients who were not expected to require therapeutic procedures, such as balloon dilation or hemostasis, were selected from 108 patients who were planned to undergo SBE at Keio University Hospital between May and December 2017 and underwent enteroscopy using the novel ultrathin single-balloon enteroscope system. Among these patients, seven underwent transoral enteroscopy and 21 underwent transanal enteroscopy. Informed consent was obtained from all patients before the procedure. Information on patient demographics, clinical and procedural data, and adverse events were collected from the medical charts, along with details of the endoscopy procedure that were collected using the endoscopy reporting system (Solemio ENDO; Olympus, Tokyo, Japan).

Single-balloon enteroscopy procedures

All patients were consciously sedated with pethidine hydrochloride 35 mg and flunitrazepam 0.2 mg. If patients experienced severe pain during the procedure, the operator added flunitrazepam in 0.2-mg increments as required. All 28 endoscopic examinations were carried out by three expert endoscopists who were Board Certified Fellows of the Japan Gastroenterological Endoscopy Society. All procedures were carried out by either the single- or dual-operator method [7]. CO₂ gas was used for insufflation in all patients, and fluoroscopy was used routinely during the procedure.

Total procedure time was defined as the time from the insertion to withdrawal of the enteroscope. Insertion depth was measured in cm according to the method defined by May et al. [8] or by measuring the amount of small bowel traversed on withdrawal in 5 – or 10-cm increments [9].

The study was carried out with the approval of the ethics committee of Keio University (approval number 20160431).

Single-balloon system

The ultrathin single-balloon enteroscope system consisted of a video enteroscope (SIF-Y0018; Olympus), a sliding tube with a balloon (ST-Y0005; Olympus), and a balloon controller unit (Olympus). The features of the ultrathin single-balloon enteroscope are compared with a conventional single-balloon enteroscope (SIF-Q260; Olympus) in [Table 1] and [Fig. 1]. The ultrathin single-balloon enteroscope has a working length of 2000 mm, with a distal-end outer diameter of 5.4 mm, insertion-tube outer diameter of 6.5 mm, and a working-channel diameter of 2.2 mm, which allows only the use of biopsy forceps. It has additional features including so-called “passive bending,” whereby a secondary bending section, located close to the primary bending section at the distal end of the enteroscope, can be bent passively and is highly flexible ([Fig. 1c]).

The features of the sliding tube are shown in [Table 1]. The sliding tube for the ultrathin single-balloon enteroscope has a working length of 1320 mm, with an outer diameter of 9.9 mm and inner diameter of 7.7 mm. The length and outer diameter of its balloon are the same as for the conventional sliding tube. The balloon can be inflated and deflated by the balloon controller, with a pressure range of –6.0 to 6.0 kPa.

Results

There were 28 ultrathin SBE procedures performed (7 transoral, 21 transanal). The demographic and clinical characteristics of the patients are shown in [Table 2]. The two patients with suspected lymphoma were diagnosed as having follicular lymphoma, and the three with suspected enteritis were diagnosed as having eosinophilic enteritis (n = 2) and eosinophilic granulomatosis with polyangiitis (n = 1) by targeted biopsies. Targeted biopsies were also performed at known polyps on a patient with familial adenomatous polyposis (FAP) to evaluate malignant potential. Disease activity was evaluated on patients with Bechet’s disease, Crohn’s disease, and chronic enteropathy associated with SLCO2A1 (CEAS) by targeted observation and/or biopsies.

Details of the transoral and transanal enteroscopy procedures are shown in [Table 3]. All transoral procedures were completed safely. The mean examination duration was 24.7 minutes (range 13 – 35 minutes). The rate of intubation beyond the ligament of Treitz was 100 %, and the mean insertion depth was 138.6 cm (range 120 – 200 cm). The mean dose of additional flunitrazepam was 0.74 mg (range 0.6 – 0.8 mg). All transanal procedures were also completed safely. The mean examination duration was 40.0 minutes (range 26 – 58 minutes). The mean cecal intubation time was 12.3 minutes and the rate of terminal ileal intubation was 100 %. The mean insertion depth from the ileocecal valve was 64.6 cm (range 15 – 200 cm). The mean dose of additional flunitrazepam was 0.01 mg (range 0.0 – 0.2 mg). No adverse events related to the procedure, such as perforation, bleeding, or pancreatitis, were reported in any patients.

Endoscopic and fluoroscopic views in a representative patient with Crohn’s disease are shown in [Fig. e2] (available online in Supplementary material). It was possible to pass the ultrathin enteroscope through an area of severe stenosis, allowing insertion to the end of the ileum and evaluation of the area beyond the stenosis, which had been difficult to observe by conventional SBE.

Discussion

The clinical usefulness of a small-caliber endoscope for EGD and colonoscopy has been demonstrated in numerous studies [6] [10] [11], but the usefulness of an ultrathin endoscope remains controversial. The main advantage of a small-caliber endoscope is its comfort and tolerability for the patient, associated with its low degree of invasiveness. However, an ultrathin endoscope also has some drawbacks. A previous study showed that an ultrathin endoscope had poor operability because of its extreme flexibility and its insertion failure rate in EGD was 6.1 % [5]. In addition, the narrow working channel of an ultrathin endoscope, with a diameter of 2.2 mm, made it difficult to perform therapeutic procedures, other than biopsies, owing to insufficient suction and air insufflation compared with a standard endoscope, which resulted in longer procedure times [5] [12].

In the current study, we evaluated the feasibility of using a novel ultrathin single-balloon enteroscope, but the disadvantages did not affect the observation of the small-bowel mucosa and targeted biopsy. The insertion depth in the small bowel was adequate to achieve the objective of the enteroscopy in all patients undergoing either transoral or transanal enteroscopy in a single-arm setting. Moreover, the mean examination duration, mean insertion depth, intubation rate beyond the ligament of Treitz, cecal intubation rate, and terminal ileal intubation rate were similar to a previous report using conventional SBE [9].

The mean sedative dose in the current study, especially in transanal procedures, was markedly lower using the novel ultrathin enteroscope compared with the conventional enteroscope in our hospital, with a mean dose of additional flunitrazepam of 0.01 mg (range 0.0 – 0.2 mg) for the ultrathin enteroscope, compared with 0.2 mg (range 0.0 – 0.6 mg) in 45 patients using the conventional enteroscope for transanal enteroscopy without therapeutic procedures, such as balloon dilation or hemostasis, during the same period. Use of an ultrathin single-balloon enteroscope might therefore reduce pain during enteroscopy compared with the conventional single-balloon enteroscope.

In addition, another advantage of the ultrathin enteroscope is shown in Fig. e2. This result suggested that the use of an ultrathin enteroscope could allow evaluation in more severe stenoses than the conventional single-balloon enteroscope.

The limitations of this feasibility study were its small sample size and single-arm setting. Further randomized controlled studies with larger samples are therefore needed to confirm the performance of this novel ultrathin single-balloon enteroscope.

In conclusion, this novel ultrathin single-balloon enteroscope provides adequate insertability and safety for surveillance enteroscopy under conscious sedation. Transanal ultrathin SBE was able to evaluate the proximal part of the bowel, even in the presence of severe stenosis that prevented a conventional enteroscope being passed through. Moreover, use of the ultrathin enteroscope decreased the amount of sedative drug administered, meaning ultrathin SBE may be associated with reduced patient discomfort during the procedure.

Competing interests

The prototype single-balloon enteroscope was provided by Olympus.

Acknowledgments

We thank Susan Furness, PhD from Edanz Group (www.edanzediting.com/ac) for editing a draft of this manuscript.

• References

• 1 Yamamoto H, Sekine Y, Sato Y. et al. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc 2001; 53: 216-220
  CrossrefPubMedSearch in Google Scholar
• 2 Tsujikawa T, Saitoh Y, Andoh A. et al. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy 2008; 40: 11-15
  Thieme ConnectPubMedSearch in Google Scholar
• 3 Rondonotti E, Spada C, Adler S. et al. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy 2018; 50: 423-446
  Thieme ConnectPubMedSearch in Google Scholar
• 4 Sethi S, Thaker AM, Cohen J. et al. Monitored anesthesia care without endotracheal intubation is safe and efficacious for single-balloon enteroscopy. Dig Dis Sci 2014; 59: 2184-2190
  CrossrefPubMedSearch in Google Scholar
• 5 Atar M, Kadayifci A. Transnasal endoscopy: Technical considerations, advantages and limitations. World J Gastrointest Endosc 2014; 6: 41-48
  PubMedSearch in Google Scholar
• 6 Sato K, Ito S, Shigiyama F. et al. A prospective randomized study on the benefits of a new small-caliber colonoscope. Endoscopy 2012; 44: 746-753
  Thieme ConnectPubMedSearch in Google Scholar
• 7 Ohtsuka K, Kashida H, Kodama K. et al. Diagnosis and treatment of small bowel diseases with a newly developed single balloon endoscope. Dig Endosc 2008; 20: 134-137
  CrossrefPubMedSearch in Google Scholar
• 8 May A, Nachbar L, Schneider M. et al. Push-and-pull enteroscopy using the double-balloon technique: method of assessing depth of insertion and training of the enteroscopy technique using the Erlangen Endo-Trainer. Endoscopy 2005; 37: 66-70
  Thieme ConnectPubMedSearch in Google Scholar
• 9 Upchurch BR, Sanaka MR, Lopez AR. et al. The clinical utility of single-balloon enteroscopy: a single-center experience of 172 procedures. Gastrointest Endosc 2010; 71: 1218-1223
  CrossrefPubMedSearch in Google Scholar
• 10 Horiuchi A, Nakayama Y. Unsedated ultrathin EGD by using a 5.2-mm-diameter videoscope: evaluation of acceptability and diagnostic accuracy. Gastrointest Endosc 2006; 64: 868-873
  CrossrefPubMedSearch in Google Scholar
• 11 Ai ZL, Lan CH, Fan LL. et al. Unsedated transnasal upper gastrointestinal endoscopy has favorable diagnostic effectiveness, cardiopulmonary safety, and patient satisfaction compared with conventional or sedated endoscopy. Surg Endosc 2012; 26: 3565-3572
  CrossrefPubMedSearch in Google Scholar
• 12 Tatsumi Y, Harada A, Matsumoto T. et al. Current status and evaluation of transnasal esophagogastroduodenoscopy. Dig Endosc 2009; 21: 141-146
  CrossrefPubMedSearch in Google Scholar

Corresponding author

• References

• 1 Yamamoto H, Sekine Y, Sato Y. et al. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc 2001; 53: 216-220
  CrossrefPubMedSearch in Google Scholar
• 2 Tsujikawa T, Saitoh Y, Andoh A. et al. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy 2008; 40: 11-15
  Thieme ConnectPubMedSearch in Google Scholar
• 3 Rondonotti E, Spada C, Adler S. et al. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy 2018; 50: 423-446
  Thieme ConnectPubMedSearch in Google Scholar
• 4 Sethi S, Thaker AM, Cohen J. et al. Monitored anesthesia care without endotracheal intubation is safe and efficacious for single-balloon enteroscopy. Dig Dis Sci 2014; 59: 2184-2190
  CrossrefPubMedSearch in Google Scholar
• 5 Atar M, Kadayifci A. Transnasal endoscopy: Technical considerations, advantages and limitations. World J Gastrointest Endosc 2014; 6: 41-48
  PubMedSearch in Google Scholar
• 6 Sato K, Ito S, Shigiyama F. et al. A prospective randomized study on the benefits of a new small-caliber colonoscope. Endoscopy 2012; 44: 746-753
  Thieme ConnectPubMedSearch in Google Scholar
• 7 Ohtsuka K, Kashida H, Kodama K. et al. Diagnosis and treatment of small bowel diseases with a newly developed single balloon endoscope. Dig Endosc 2008; 20: 134-137
  CrossrefPubMedSearch in Google Scholar
• 8 May A, Nachbar L, Schneider M. et al. Push-and-pull enteroscopy using the double-balloon technique: method of assessing depth of insertion and training of the enteroscopy technique using the Erlangen Endo-Trainer. Endoscopy 2005; 37: 66-70
  Thieme ConnectPubMedSearch in Google Scholar
• 9 Upchurch BR, Sanaka MR, Lopez AR. et al. The clinical utility of single-balloon enteroscopy: a single-center experience of 172 procedures. Gastrointest Endosc 2010; 71: 1218-1223
  CrossrefPubMedSearch in Google Scholar
• 10 Horiuchi A, Nakayama Y. Unsedated ultrathin EGD by using a 5.2-mm-diameter videoscope: evaluation of acceptability and diagnostic accuracy. Gastrointest Endosc 2006; 64: 868-873
  CrossrefPubMedSearch in Google Scholar
• 11 Ai ZL, Lan CH, Fan LL. et al. Unsedated transnasal upper gastrointestinal endoscopy has favorable diagnostic effectiveness, cardiopulmonary safety, and patient satisfaction compared with conventional or sedated endoscopy. Surg Endosc 2012; 26: 3565-3572
  CrossrefPubMedSearch in Google Scholar
• 12 Tatsumi Y, Harada A, Matsumoto T. et al. Current status and evaluation of transnasal esophagogastroduodenoscopy. Dig Endosc 2009; 21: 141-146
  CrossrefPubMedSearch in Google Scholar

• Supplementary Material