Summary

Objective: To study the feasibility of performing diagnostic esophago-gastro-duodenoscopy (EGD) via the trans-nasal route in an office-based setting in the local population.

Design: Prospective observational study.

Subjects: The out-patient clinic of a private gastroenterologist in Hong Kong. Starting from January 2005 and for a consecutive period of 18 months, all Chinese patients undergoing diagnostic EGD in the author's clinic were recruited for Trans-nasal EGD (T-EGD). Patients who were excluded from T-EGD or failed T-EGD were offered either unsedated per-oral EGD (P-EGD) or sedated per-oral EGD (C-EGD) using the same ultra-thin endoscope, according to patient's own choice.

Main outcome measures: Patient acceptability, side-effects, success rate, technical adequacy, and image quality of the procedure.

Results: 102 patients attempted T-EGD. 101 patients (99%) underwent the procedure successfully. One patient (1%) failed the procedure due to phobia attack. Patient acceptance was 1.39 + 0.76 and willingness to repeat the same procedure was 1.36 + 0.67 (mean + SD) over a 5 point Likert scale (1 being totally acceptable and 5 being totally unacceptable). All the successful T-EGD were technically adequate with good image quality.

Conclusion: Unsedated trans-nasal EGD is a safe office-based procedure which is technically adequate for diagnosis of upper GI diseases, and has good patient acceptance in this patient population in Hong Kong. Without sedation, it is a simpler and relatively safer procedure than similar procedures performed under intravenous sedation. Together with satisfactory patient acceptance, this procedure is particularly suited for office-based EGD in the private practice setting.

Keywords: Esophagogastroduodenoscopy, Conscious sedation, Hong Kong

摘要

目的：研究本地病人在門診環境下進行經鼻診斷性食道胃十二指腸鏡檢查(EGD)的可能性。

設計：前瞻性觀察性研究。

對象：香港一所私家胃腸病科醫生診所。從 2005年1月開始的連續18個月，所有在作者該診所內需要進行診斷性EGD檢查的華裔病人都安排接受經鼻EGD(T-EGD)檢查。未接受T-EGD或T-EGD失敗的病人，則根據他的意願，採用同一超幼細內窺鏡，接受無鎮靜劑經口EGD(P-EGD)或在接受鎮靜劑後經口EGD(C-EGD)。

測量內容：病人對檢查的接受程度、不良反應、成功率，技術上的適當程度和影像質素。

結果：102名病人進行了T-EGD。101人(99%)順利地接受檢查過程。1人(1%)因出現恐懼而放棄該檢查。在 5分（1為完全接受，5為完全不接受）的Likert尺規上，病人接受度為1.39+0.76；願意再次接受同樣程序的程度為36+0.6 7（平均值+標準差）。所有成功地進行的T-EGD，技術上均屬足夠。而且影像質素良好。

結論：無鎮靜劑經鼻EGD是一種可安全地在門診診斷上消化道疾病的檢查方法，技術上可行，而病人接受度良好，因無需使用鎮靜劑與在靜注鎮靜劑後進行類似檢查相比，它較為簡單，而且更為安全。加上病人對過程頗為接受，經鼻EGD檢查會特別適合在私家診所環境下進行。

主要詞彙：食道胃十二指腸鏡，清醒狀態鎮靜，香港

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Introduction

Conventionally, diagnostic esophago-gastro-duodenoscopy (EGD) in western countries^1,2 is performed per-orally and under conscious sedation (C-EGD).

The practice of unsedated EGD using conventional sized instruments (outer diameter >9mm) varies widely globally.³ A double blinded randomized controlled trial using a 9.8 mm endoscope revealed that the overall patient acceptance of unsedated EGD with this instrument is 47%, with 65% patients willing to undergo the same procedure under similar test conditions.⁴

In recent years, there has been an increasing trend towards performing unsedated EGD.⁵ Development of ultra-thin endoscopes, with outer diameter 6mm or less, provides better patient acceptance⁶ and would help this trend to gain momentum.

Shaker first described in 1994 a technique of performing unsedated EGD through the nose (T-EGD),⁷ using an ultra-thin endoscope. The major advantage of such approach is that it obviates the use of conscious sedation, together with its inherent cost and side-effects. Since then this technique had been validated in large scale studies to be technically feasible, safe, with high patient acceptance.^8,9 The same instrument can also be used per-orally, without sedation (P-EGD). Overall patient acceptance of T-EGD and P-EGD are similar,¹⁰ but T-EGD causes significantly less gagging.¹¹ However, in one study with an instrument of outer diameter 6mm, T-EGD patients experienced significantly more pain than P-EGD patients.¹² It is worthwhile to examine if refinement of ultra-thin endoscopes, with smaller outer diameter, will ameliorate patient discomfort with T-EGD.

Patient acceptance of unsedated EGD may vary with different ethnicity and culture background. Thus far, there have been no studies of T-EGD in Hong Kong among the indigenous population, which comprises mainly southern Chinese (predominately Cantonese). In addition, comparative acoustic rhinometry has shown that the Nasal Minimal Cross-sectional Area (NMCA) among Asians is smaller than that of Caucasians and Blacks.¹³ One study on Chinese revealed that the mean NMCA to be only 0.55 sq cm.¹⁴ Whether the smaller NMCA poses greater technical difficulty in navigating the endoscope through the nose among Hong Kong patients remains to be seen.

This study was aimed at examining the applicability of T-EGD in the local population with a new ultra-thin endoscope. It attempted to address, in particular, issues on technical adequacy, and patient acceptance of T-EGD as an out-patient procedure.

Methods The author is a gastroenterologist in private practice. This study was carried out in an out-patient clinic which is the author's solo practice. Starting from January 2005 and for a consecutive period of 18 months, all Chinese patients who needed to undergo EGD in the clinic were recruited. The author was the sole endoscopist for these patients. Inclusion criteria All eligible Chinese patients seen at the author's clinic, where diagnostic out-patient EGD was indicated, were offered T-EGD initially. All patients who failed T-EGD would be offered unsedated P-EGD or sedated C-EGD. The choice of P-EGD versus C-EGD was discussed with and agreed upon by the patient. Patients were also given the option for initial P-EGD or C-EGD by personal choice. Exclusion criteria T-EGD was excluded in patients where therapeutic procedures might be expected, e.g. patients with active GI bleeding. Patients with recent nasal or sinus operations, infections, or prominent nasal allergy, as well as patients who refused T-EGD due to fear of the procedure or any other personal reasons, were also excluded. Instrument Pentax model EG-1580K ultra-thin endoscope was used. It has an outer diameter of 5.1 mm, working channel of 2.0 mm, with 210 degrees up, 120 degrees down, and a 1050 mm working length. There is no left and right deflection in this model. The video image of this endoscope is produced by color (RGB) CCD. The procedure Virtually all patients initially expected the procedure to be performed under sedation, so the first task was to "educate" them to take unsedated T-EGD. A thorough explanation of the procedure, its indication, benefits, limitations, possible side-effects, and alternative options were given by the endoscopist. Written and informed consent was obtained from every patient. T-EGD was generally performed in the morning after overnight fasting. Patients who already had breakfast at their initial visit but desired to have T-EGD preformed the same day could have their lunch omitted and have the procedure done in the afternoon after fasting for 6 hours. The Shaker technique7 was used for the procedure. After adequate explanation, the patient underwent the examination in the up-right (sitting) position. The more patent side of the nostril was chosen for the procedure. Local anaesthesia was achieved in the oral pharynx with 10% xylocaine spray, and in the nose with application of 2% xylocaine jelly. Iliadin (0.05% Oxymetazoline HCl) was then sprayed to the nose to provide decongestion of the nasal mucosa. The endoscope was gently advanced under direct vision through the nostril, nasal cavity, into the oral pharynx. The patient was then asked to swallow to relax the superior sphincter and enable the instrument to enter the esophagus. After visualizing the esophagus, the stomach was next examined in forward view and in retroversion. The pylorus was then entered and the duodenal bulb and the second part of the duodenum scrutinized. On return to the stomach, antral biopsy was routinely taken for CLOtest for detection of helicobacter infection. As the patient was fully conscious, the endoscopist communicated with the patient on the relevant findings during the procedure. The whole procedure was recorded by VCD (a few by DVD). After the procedure, the endoscopist reviewed and discussed the recording with the patient, and at the same time extracted selective images for photo recording to be incorporated into patient's endoscopy report. The written report, with the photos, was usually handed to the patient after the consultation, together with the VCD (or DVD). The following data were entered:
1)	Patient demography
2)	Endoscopy diagnosis
3)	Time taken for procedure
	i)	Preparation Time: Time taken to anaesthetize nose, pharynx (+ Iliadin nasal spray for T-EGD/IV sedation for C-EGD)
	ii)	Procedure Time: Time taken to perform the EGD (from intubation to extubation)
4)	Technical adequacy The procedure was considered technically adequate and complete if it enabled complete and clear visualization from the larynx to the second part of duodenum, namely:
	i)	Esophagus and esophageal-gastric junction
	ii)	Stomach (forward view)
	iii)	Stomach (retroverted view)
	iv)	Duodenum (including first and second part)
	Any inadequacy in a given patient was recorded as incomplete examination.
5)	Patient acceptance Patient discomfort (gagging, choking and pain), as well as overall acceptance, was surveyed as a verbal questionnaire after T-EGD using the Likert Scale (5 point scale: 1=completely acceptable, 2=acceptable, 3=undecided, 4=unacceptable, 5=completely unacceptable), similar to the method used in a Canadian study.4
6)	Patient willingness to undergo same procedure. This was again rated with a five point Likert Scale as above.

Results

During the 18 month period starting from January 2005, one patient (No. 103) underwent unsedated per-oral EGD (P-EGD) because of significant nasal allergy. Except for this exclusion, all other patients in whom EGD were indicated, were offered EGD via the trans-nasal route (T-EGD). After detailed explanation of the procedure, including its risks and benefits, limitations and alternatives, none of these patients had opted for initial P-EGD or C-EGD instead of T-EGD. The total number of T-EGD attempted was 102 consecutive Chinese patients. Of these 102 patients who attempted T-EGD, one patient (No. 13) had phobia attack during the procedure and eventually underwent sedated per-oral EGD (C-EGD) smoothly. This patient is counted as failure of T-EGD (1%). For the other 101 patients, T-EGD was performed successfully (99%).

Demography

Patient demography is shown in Table 1.

Of the T-EGD group, the male to female ratio was 1:1.3. The median age was 51, with age range 21-95.

Indications

Indications for the EGD are shown in Table 2.

The major indications in the T-EGD group were dyspepsia and acid regurgitation symptoms. Other indications ranged from post-operative cancer surveillance to weight loss and anaemia for investigation.

Time taken for each procedure

Time taken for each procedure is shown in Table 3.

The median time required for the examination was 8 minutes (range 3-34 minutes).

Diagnosis

The endoscopy diagnoses are summarized in Table 4.

The major endoscopic diagnoses were gastritis and duodenitis. Among the 51 patients with negative endoscopic findings, 13 were diagnosed to have Endoscopy Negative Reflux Disease basing on symptoms.

Technical adequacy

All successful T-EGD achieved adequate and complete visualization from larynx to second part of duodenum.

Image quality

For all the procedures, the endoscopist visually evaluated the image quality, and further scrutinized the recording as well as the photographs captured.

The image quality displayed by the monitor during the procedure was consistently good, and comparable with conventional instruments in displaying the details. Additionally, the recording on either VCD or DVD, was also consistently clear. There was no apparent difference in the image quality between photos captured from the VCD or DVD, as both were clear.

Patient discomfort and acceptance

Patient discomfort (gagging, choking and pain), as well as overall acceptance, was found to be at an acceptable level. It is shown in Table 5. The mean pain score of 1.42 was well within patients' own "acceptable" range. The overall acceptance level was also good at 1.36.

The pain experienced during the procedure was generally mild and tolerable with no sedation. Most patients however complained of some gastric distension while being fully awake during the procedure.

In one patient (No. 85), there was self-limiting epistaxis. Another patient (No. 14) had vasovagal attack during the procedure with sweating and dizziness towards the end of examination. The examination was completed however, and he recovered spontaneously.

Willingness to repeat procedure for T-EGD

Willingness to repeat the procedure was also recorded on a 5 point Likert Scale graded as above. The mean willingness score was 1.39 (SD=0.76), between "completely acceptable" and "acceptable".

Discussion

This study shows that the discomfort during T-EGD is generally acceptable to the patient, and the overall acceptance of the procedure is high. Most patients are willing to repeat the procedure (if needed).

Age was reported to be an important factor in patient acceptance, when conventional 9.8 mm endoscope was used for unsedated per-oral endoscopy.⁴ Older patients tended to have less gagging with the per-oral route, probably due to their decreased pharyngeal sensitivity, and thus better tolerance. However, analysis of the present group of patients using the trans-nasal route and has found that acceptance has no direct relationship to age. There is also no significant difference between examination-time taken for the younger and the older patients.

As mentioned, patients commonly experienced some extent of gaseous distension. This can be alleviated by judicious use of minimal distension necessary and encouraging the patient to belch during the procedure.

Admittedly, even experienced GI endoscopists may be unfamiliar with performing EGD via the trans-nasal route, though prior experience of conventional EGD is a pre-requisite to embark on T-EGD. A learning curve is generally needed for GI endoscopists who decide to use this newer procedure. The most unfamiliar anatomy for a gastroenterologist performing T-EGD is of course the nose, which is traditionally the territory of ENT surgeons.

Trans-nasal flexible endoscopy, in the form of fiberoptic rhinolaryngoscopy, has actually been practised by ENT surgeons for a much longer period than the T-EGD. ENT/Head and Neck surgeons in recent years have also used office-based, unsedated trans-nasal esophagoscopy with consistently good patient tolerance and safety record. ^15,16 Coaching from ENT colleagues in navigation through the nose will be invaluable to GI endoscopists who want to practise T-EGD, as was the case of the author.

In addition, a few minor technical deviations from the traditional EGD procedure are also required to be mastered. There is no left/right deflection in the endoscope, so the endoscopist needs to use his trunkal (axial) movement to achieve this end. Lens cleansing may be more difficult as there is no separate channel for lens cleansing.

The office computer also records the time taken from the "finish" of T-EGD to patient's leaving the clinic. This record is not entered into this study for the following reasons. Theoretically, a patient undergoing unsedated EGD may leave the clinic right after the procedure. However it is the author's practice to take time after the procedure to personally review and discuss the video recording with the patient. Thus this time-span only reflects the time the physician spent with the patient after the procedure. This varies with the different styles of clinical practice and does not reflect patient's recovery time. Physician time can be saved, for example, if the task of discussion and explanation after the procedure is assumed by an experienced nurse practitioner.

As the patient can resume his or her daily routine right after EGD, time saved by patients can be substantial. In this regard, T-EGD is in sharp contrast to conventional sedated EGD, where the patient not only requires time to recover from the sedation, residual lethargy may persist throughout the rest of the day, precluding meaningful working, driving, or other daily activities.

Cost reduction of unsedated EGD include obviating medication for sedation, recovery room costs, extra nursing personnel involved, time taken off work and/or social engagements for the patient, and possibly time taken for an escort to accompany or to drive the patient home after the procedure. The audit of these costs is complicated and was not done in this study.

Obviation of sedation reduces its inherent risks, which can be considerable.⁴ Risk reduction is especially invaluable in high-risk groups, e.g. in patients with advanced cirrhosis, or cardio-pulmonary insufficiency. Being relatively safe, it is especially useful in an office setting on an outpatient basis.

Special indications include patients with esophageal strictures which only allow passage of an ultra-thin endoscope. The procedure is also specially incidated in the occasional patient in whom the per-oral route is not feasible.¹⁷

The study did not examine the adequacy for biopsy for histology studies and/or CLOtest, as these have been well documented to be adequate in previous studies.^18-20

This study did not monitor oxygen saturation or blood pressure fluctuation on the assumption that these parameters remain stable during the procedure, as reported in similar studies.²¹ However, oxygen desaturation has been reported,²² as well as one esophageal perforation, in T-EGD.¹²

Therefore T-EGD should be practised with due caution and prudence. It is worth considering oxygen and blood pressure monitoring in selected high risk patients who undergo T-EGD, e.g. in patients with significant cardiopulmonary insufficiency.

It is hoped that in the future, further miniaturization will produce even thinner endoscopes for better patient tolerance; further technical refinements to enable T-EGD to have left/right deflections, and better lens cleansing, so that they become more user friendly, leading to wider acceptance among endoscopists. Therapeutic options, hopefully, would then follow suite.

Acknowledgement

The author is especially grateful to Professor R Shaker for teaching him the Shaker Technique.

Key messages

1. Trans-nasal Esophago-Gastro-Duodenoscopy (T-EGD) is a relatively new yet well established approach of performing routine diagnostic EGD.
2. It usually requires no conscious sedation and as such is better suited as an office-based procedure.
3. Performed this way, it has a proven safety record and has good patient acceptance in western countries.
4. This study shows that it is well accepted by local patients under the study conditions here in Hong Kong.

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References