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Endoscopic Bariatric Procedures

and Devices

Kiyoshi Hashiba, MDDepartment of Surgery, Sao Paulo University Medical School, Rua Anatolia,

105, Sao Paulo 05471-000, Brazil

Since the discovery of a correlation between bezoars and weight loss in

the early twentieth century, the medical community has been hopeful about

the use of iatrogenic bezoars for minimally invasive weight reduction endo-

scopic treatment [1]. Only recently the presentation of other modalities

started. The devices that can be applied in the endoscopic treatment of obe-

sity may be divided now into three categories: those that occupy a space in

the gastric lumen, those that make a restriction in the stomach lumen, andfinally the devices that alter food absorption. The interest in endoscopic

treatment of obese patients is growing as a result of the technical develop-

ment of endoscopic devices and because several studies have shown that

most patients do not need the substantial weight loss afforded by bariatric

surgery procedures. This article reviews current and investigational projects

and devices not available in the market.

Gastric volumedisplacing weight loss devices (GVDD)

The intragastric balloons are the most important representatives of these

kinds of devices. They are intended to make a reduction in food intake and

body weight due to early satiety.

Animal studies seem to confound the argument by positively showing ef-

ficacy in dogs and rats [2,3]. When balloons of a particular volume were

placed in these animals, a reduction in food intake caused some weight

loss, although it should be noted that this effect diminished when the

balloon volume was reduced, indicating presence of some volume threshold

below which the balloon has no physiologic effect and above which patients

report undesirable symptoms. This volume varies with population. The

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Gastrointest Endoscopy Clin N Am

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sensations of satiety, fullness, bloatedness, and nausea can all be induced

by different volumes; however, the correlation is not so straightforward

[4,5].The true mechanisms triggering weight loss from volume-displacing de-

vices are inconclusive. Isolating a particular mechanism or combination of

mechanisms is difficult because of the many factors that can be attributed

to weight loss. Hypotheses for weight loss from intragastric balloons include

delayed gastric emptying, mechanical volume reduction, hormonal changes,

and neuronal effects.

The general idea is well perceived and could possibly result in weight loss

because of an increased sense of fullness for a longer period of time. Studies

conducted with large devices such as the 600-mL saline-filled BioentericsIntragastric Balloon (BIB) (Bioenterics Corp., Carpinteria, CA) [6] or the

500-mL air-filled Ballobes [7] report a decrease or slowing of gastric

emptying rates. However, there are studies performed with Garren-Edwards

[810] and Willmen gastric bubble [11] that are conflicting.

The idea of weight loss from a volume-displacing device is the occupation

of a large volume of the stomach and reduction in its capacity to store food.

With reduced capacity to store foods, one subsequently eats less because of

an early feeling of fullness. Studies conducted by Durrans and colleagues [3],

suggest that the 200 mL balloon had no significant effect in intake whereasthe 500 mL balloon reduced energy intake.

Some chemical and biochemical markers stimulate and suppress appetite

and satiety. Cholecystokinin (CCK) has been shown to be associated with

appetite suppression. The relation of the serum marker elevation to the

balloon is not clear, but one study [12] showed that CCK reduced gastric

pressure in response to increasing balloon volume.

On the neuronal effects, it seems that distending the stomach stimulates

gastric stretch receptors, thus triggering vagal discharges that activate hypo-

thalamic neurons and induce the feeling of satiety [13].However, there are hypotheses that reject the idea that the weight loss is

device-induced and attribute the weight loss to diet modifications, behavior

changes, and placebo effects [14].

In general, the intragastric devices are not recommended in patients with

a disease of the upper digestive tract. Patients with malignancy, pregnancy,

alcoholism, and drug abuse are also excluded.

The first intragastric device to be commercialized was the Garren-

Edwards balloon. Because of issues regarding the efficacy and safety of

the concept itself, it was withdrawn from the market after few years of use.At present, the BIB and the Heliosphere Balloon (HB) (Helioscopie SA,

Vienne Cedex, France) seem to have found a niche in the international

iatrogenic bezoar market. Both balloons are smooth and spherical. The shell

is made of inert, nontoxic silicone elastomer, impervious and resistant to

gastric acid. The HB has two layers of the same sheet. Both of them have

a valve to retain liquid (BIB) and air (HB), connected with a balloon fill

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tube. The balloon is inserted collapsed within a sheath of plastic (BIB) or

cloth (HB).

Balloons insertion

Both balloons can be inserted under conscious sedation. This introduc-

tion is not controlled by endoscopy or radiograph. The balloon placement

assembly is inserted a distance from the incisor teeth and calculated so as

to be located 10 cm distal to the esophagogastric junction. The procedure

is easily performed, although the collapsed HB is more rigid. In both cases

a hand maneuver is needed to help the introduction in the hypopharynx.

The BIB usually is filled with a solution of methylene-blue (Fig. 1).The balloons when filled adequately may cause some symptoms in the

postendoscopic period. It is important to observe the patient in the hospital,

because nausea, vomiting, and abdominal cramps are common. To control

these undesirable events, it is important to start symptomatic medications (an-

tiemetics and antispasmodics) immediately after insertion. These symptoms

are expected to last 72 hours, but, in few patients, they are uncontrolled and

the balloon needs to be removed. These events are less frequent and intense

with the HB [15]. On discharge, the patients are given a balanced diet of

around 1000 to 1500 kcal per day. Physical activity is also recommended.

Balloons removal

For balloon removal, as much fluid as possible should be removed in the

first step, using a needle or one catheter. The BIB balloon can be grasped

with a snare or a forceps. Finally, the endoscope and the balloon are removed.

Usually this procedure is easily performed. The same does not occur with the

Fig. 1. The BIB in a stomach filled with colored liquid.

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HB. In this case, after the maximum aspiration of the balloon, a specific device

must be used. This device has two claws that catch the balloon in the valve

(Fig. 2). The HB always finds a resistance in the cardia and the operator hasto wait for the relaxation of the muscles of the esophagogastric junction

area. Sometimes the first maneuver is not successful and the balloon has to

be grasped again. In this case, the removal procedure conducted with snare

and basket usually results in important esophageal trauma.

Results

During the implant period, the rate of weight loss typically increases in

the first week, remains constant for 3 to 4 additional weeks, and finally de-

creases as patients presumably adapt to the device. Probably, the distended

stomachs increased capacity might contribute to increased food intake and

therefore decrease the rate of weight loss [2]. The treatment is effective in

well-motivated patients as a method for losing around 1 kg per week.

Most published studies are on the BIB balloon. For one of them [16], pa-

tients were invited for a randomized, double-blind trial of balloon or sham

treatment of 3 months duration. Only patients who achieved weight loss

were given an additional 9-month treatment. Forty-three patients held an av-

erage body mass index (BMI) of 43.3. Balloon and sham groups had similar

mean weight loss during the first 3 months. Balloon/balloon patients lost

significantly less weight in months 3 to 6 than did sham/balloon patients, evi-

dencing the weight loss plateau effect. Patients who completed the study per

protocol lost 25.6 kg (20.5%) after 1 year and 14.6 kg (11.4%) after 2 years.

A double-blind, sham-controlled, randomized and crossover study con-

ducted by Genco and colleagues included 32 patients with BMI of 40 to

45 and lasted 6 months [17,18]. The balloon group had a significant

Fig. 2. The HB after the complete deflation.

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reduction in BMI from 43.5 to 38.0. The authors concluded that in associ-

ation with appropriate diet, the device is significantly effective in weight re-

duction as compared with sham procedure plus diet control.At the Srio Libanes Hospital (SLH) in Sao Paulo (Brazil), an open pro-

spective study included 41 patients who did not respond to medical therapy.

A dietitian instructed each subject to consume a diet with 1200 kcal. On the

first and second days after the insertion, the patients received liquids, 200

mL, 8 times a day. Only water was allowed in the intervals. From the third

to seventh days of the postoperative course they received 7 times, 200 mL

of a full liquid diet. Between the 8th and the 30th days the patients received

200 g or 200 mL of a soft solid diet. The patients remained in the hospital for

1 day. Antiemetic and antispasmodic medications were administered for8 days. Acid suppressant drugs were given during all the treatment. Physical

activity was advised. There were no complications in the insertion and re-

moval procedures. The mean initial weight was 112.07 kg and the BMI,

38.7. The final results were 92.45 kg and 32.4, respectively. No balloons de-

flated during the treatment. Only three were removed early. In one case, the

patient revealed intolerance for a long time (10 days) and in the other two,

the patients lost weight strongly in a short time (1 month) and they were

afraid to get sick. The data on the HB are limited and the results seem to

be similar to the BIB [15].

Complications

The spontaneous deflation of the balloon occurs in about 2% of cases

[16]. Probably, this is the most important adverse event in the treatment.

When the deflation occurs, the device can remain in the stomach or can

migrate distally. In some cases of migration, the balloon had to be removed

surgically. However, it is important to emphasize that most balloons lost

their contents. Some studies showed that well-functioning balloons deflateat a rate of 2 to 3 mL per day [17]. The rates of complication related to

insertion and removal are low [15,16], but unpublished data (Jermid Q

and Hashiba K, 2006) show that the HB is more difficult to remove with

the current design and it requires a special device to complete the removal

procedure after the puncture for deflation.

Other balloons

The described BIB and HB are the balloons available on the market insome parts of the world. However, since the first well-studied attempt to

treat obesity with balloons, there were other devices and few studies with

them (Table 1).

Recently, some studies were performed with a novel balloon device. It is

the Adjustable Totally Implanted Intragastric Prosthesis (ATIIP) Endogast

[19] (Districlass Medical S.A., Corbas, France).


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This device has a tube like a gastrostomy tube that keeps the balloon inplace. There are two models, one in which the gastrostomy tube has a valve

and the second in which the tube is totally implanted subcutaneously. The

advantage is the significant migration reduction and the volume control

that can be increased or decreased by the patient.

However, the difficulties in making a gastrostomy in obese patients and

the complications of the placement of the gastrostomy opening in the

abdominal wall are well known. One open study performed in patients

with mean BMI of 48.4 showed progressive weight loss: first month,

11 kg; 3 months, 18 kg; and 6 months, 22 kg. Most of the early complica-tions were a result of the gastrostomy procedure. No late postoperative

complications occurred [19].

The present results with BIB showed that it is not an alternative to suc-

cessful bariatric surgery and seems to be most appropriate as a temporazing

adjunct measure for bariatric surgery candidates. The ultimate goal would

be to provide adequate psychological motivation for patients to maintain

their modified diet, thus maximizing the benefits of the balloon. It seems

also to be a suitable treatment for not morbidly obese patients with comor-

bities. At present, there is now general agreement that the treatment shouldfocus on a sustained 10% to 15% weight loss to prevent or to reduce the risk

of cardiovascular and other obesity-related diseases [16]. Considering that

the balloon treatment is easily reversible, the balloons seem to be a very

interesting option to treat some selected obese patients. However, a strong

reliance on the placebo effect, the lack of compliance with a modified diet

and behavior, and the stigma surrounding the Garren-Edwards bubble fail-

ure prevent widespread acceptance of the concept.

A different kind of GVDD is the development of a device made with

polyethilene (Butterfly; Wilson-Cook Medical Inc., Winston Salem, NorthCarolina) [20]. In the final design of the experimental phase, a 36-meter strip

was made (Fig. 3). This long strip was 75 m thick and 3 cm wide, folded in

the middle. The strip was divided into loops of 40 cm that are put together in

bundles of seven loops so as to facilitate the insertion (Fig. 4). The loop has

a hole, each 20 cm, to allow the passing of a thread to close the device be-

tween two drags in the thread ends. A 36-cm long, 1.6-cm diameter overtube

Table 1

Overview of balloons

Name Material Approximate date Volume (mL) filling fluid ShapeGarren-Edwards Polyurethane Early 1980s 250 air Cylinder

Taylor Silicon 19891990 550 water Pear

W.Cook Polyurethane Early 1980s 300 air Pear

Ballobes Polyurethane 1980s 500 air Spherical

BIB Silicon Current 500800 water Spherical

Heliosphere Silicon Current 900 air Spherical

Endogast Silicon Current 300800 air Pear

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was used in all procedures. Canola oil was used as lubricant. The insertion

was performed in a left-side position and under general anesthesia. Intrave-

nous (IV) antibiotics were given immediately after the procedure.

The device is easily inserted and removed from the gastric lumen. Some

trauma always occurs during the insertion in the posterior wall, near the car-

dia, but it can be reduced if the stomach is kept distended. When the clinical

study started, it was difficult to compress the loops to obtain a compact

device. So, some distal loops released from the block and migrated distally

to the duodenum.

To have a compact plastic device, a 3-m long polyethylene flexible tube 75

m was used. This tube was compressed over a plastic tube used as a guide

and pusher. The compressed plastic tube has a plastic ring at every segment

of 15 cm (Fig. 4). The pusher holds the ring to insert the polyethylene tube in

a continuous movement, without the need to return to the mouth, as in the

previous design. To deploy this later generation device, it needs to come

back 15 cm to take the other segment to push. As the device has a drag

Fig. 3. Early design of the Butterfly device.

Fig. 4. Current Butterfly ready to be inserted.


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in the distal end of the central thread, when the insertion finishes, another

drag is placed in the proximal end and closes the device after a suitable com-

pression (Figs. 5 and 6).This device seems to have some advantages over the balloons, because it

does not need to be inflated or to change in any shape to work and allows

for different sizes as needed. It does not have valves to keep fluids and the

migration seems to be limited. The mechanisms of action resulting in weight

loss can also differ from those of the balloons. While the ideal position for

the balloons in the stomach is the fundus/body, the described plastic device

can move in the gastric lumen and probably distend the stomach due to its

volume and the emptying delay. However, this action can be the same as the

majority of balloons, because most of them lose their contents during thetreatment [17].

Further studies will show the real usefulness of the device to treat obese

patients.

Gastric lumen restriction with suture

The development of endoscopic suturing devices has enabled the

endoscopist to attempt an endoscopic version of the vertical gastroplasty.

One initial study [21] was performed in a postmortem specimen of porcinestomach using the endoscopic suturing device available in the US market

(Endocinch, C.R. Bard, Inc., Murray Hill, New Jersey) to treat GERD

(Gastroesophageal Reflux Disease). With this sewing machine, mounted

in the distal end of a flexible upper gastrointestinal endoscope, a tunnel

was created by suturing together the anterior and posterior walls of the

stomach near the cardia and the side of the lesser curvature. In the distal

part of this restricted area a plastic flexible ring, 3 cm in diameter, was su-

tured to the stomach. The authors suggested that the purpose of the outlet

ring was to secure the gastroplasty.

Fig. 5. The shape of the present Butterfly after the insertion maneuvers.

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Gastric reduction has also been performed in live animals using another

endoscopic suturing device [22]. The 2-0 stitches were placed in the gastricfundus, 5 cm below the gastroesophageal junction. Differently, the suture

was closed using extracorporeal knots. The authors needed 10 to 12 stitches

to obtain a gastric pouch with 30 mL at the end of the procedure. There was

no follow-up in this study.

Certainly, there are many reasons why this procedure has not become

more widely attempted. One of them is that the experience with endoscopic

sutures in GERD treatment showed that most patients (83%) lost the

stitches after 18 months [23]. Moreover, in cases of the open vertical-banded

gastroplasty, in the late postoperative course, a staple-line disruptionoccurred in 30% of cases, allowing an abnormal communication between

the stomachs and subsequent weight gain [24]. Moreover, the studies

performed in Hospital Novo Atibaia Experimental Surgery Center (Sao

Paulo, Brazil) on vertical gastroplasty in pigs with a transmural device

[25] showed a suture disruption 1 month later.

Nevertheless, a recent published report [26] on 10 patients, showed weight

loss between 15 to 49 kg after endoscopic vertical gastroplasty. The Bard

Endocinch was used in this study (Figs. 7 and 8). The BMI of patients

ranged between 25 and 35. Only one plication had to be repeated after 9months because of rupture of the suture. All patients complained of sore

throats for 2 days. No complications occurred in any procedures performed

under general anesthesia. Laboratory tests demonstrated clinical significant

reductions in cholesterol and triglycerides.

Thus, it appears that endoscopic gastric reduction is technically feasible.

With the development of new endoscopic suturing devices, more preclinical

Fig. 6. Endoscopic view of Butterfly into the stomach.


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research and new clinical studies will evaluate whether an endoscopic proce-

dure can achieve long-lasting results and determine its clinical impact.

Endoscopic devices to alter food absorption

Recently, investigators have attempted to perform an endoscopic bypass

using a sleeve in the duodenum and proximal jejunum. It consists of a very

thin polyethylene flexible tube, impermeable, attached to an autoexpandable

metal stent in the proximal end [27] (GI Sleeve, GIDinamics Inc.,

Fig. 7. Endoscopic view of the gastric restriction with Endocinch. (Courtesy of Dr. Roberto

Fogel, Caracas, Venezuela.)

Fig. 8. Radiographic study of the stomach after the Endocinch suture. (Courtesy of Dr. Rob-

erto Fogel, Caracas, Venezuela.)

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Watertown, Massachusetts). This stent has a special design to keep the

sleeve in place. Thus, food would not have contact with the mucosa fora variable length between 180 and 360 cm. For the same reason, the bilio-

pancreatic secretions are not in contact with ingested foods throughout

the same distance (Fig. 9).

After experimental studies, a feasibility and safety clinical study was per-

formed in Chile. Ten patients received the device and then 7 had it removed.

There were no complications of insertion or removal. After 90 days, the pa-

tients showed weight loss around 20% of the baseline weight. The patients

overall health improved during the treatment period.

There have been other attempts to treat obesity through endoscopy, likethe botulinum toxin antral injection [28]. However, poor results due to lack

of alteration of appetite and minimal weight loss suggest only a limited pos-

sibility with further data required.

Summary

The development of endoscopic treatments for obesity offers gastroenter-

ologists, surgeons, and endoscopists an exciting and highly desirable less-invasive therapeutic modality as compared with bariatric surgery. At

present, preliminary results cannot compare with those offered by surgical

treatment, but in selected patients, all endoscopic procedures have afforded

important improvements in patient health by reducing the comorbidities as-

sociated with morbid obesity. With the development of new techniques, the

possibility of a combined procedure can offer an interesting therapeutic

Fig. 9. GISleeve placed into the duodenum. The arrows show the sleeve. (Courtesy ofDr. Man-

oel Galvao Neto, Sao Paulo, Brazil.)


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alternative. Most modalities of endoscopic treatment of obesity are still at

a very early stage and clearly much work remains to be done. However,

the results reported in studies such as the ones discussed here should encour-age further research and development of the techniques described.

Acknowledgments

I thank Mr. Vihar Surti for helping me with the preparation of the text

and Ms. Alvamar H.C.A. Lamparelli for helping me with the manuscript

revision.

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