|Year : 2020 | Volume
| Issue : 4 | Page : 225-229
Endoscopy-guided intragastric balloon
Siddharth Mohanlal Jain, Mohan A Joshi
Department of General Surgery, Lokmanya Tilak Medical College and General Hospital, Mumbai, Maharashtra, India
|Date of Submission||21-Jul-2020|
|Date of Decision||22-Sep-2020|
|Date of Acceptance||22-Sep-2020|
|Date of Web Publication||09-Dec-2020|
Dr. Siddharth Mohanlal Jain
Department of General Surgery, Lokmanya Tilak Medical College and General Hospital, Sion, Mumbai 400022, Maharashtra.
Source of Support: None, Conflict of Interest: None
Obesity is one of the leading global health problems in the world today. It is considered a major risk factor for many serious diseases. To treat this risk factor, doctors have developed invasive and noninvasive therapeutic methods. One of these methods is the intragastric balloons (IGBs), which are known by some studies to be efficient, safe, and easy. Here, we report five cases of obese patients (three women and two men) treated by saline-filled gastric balloon insertion at our hospital. The balloons were placed endoscopically in the stomach then inflated with saline + methylene blue. After the procedure, patients were discharged within a few hours. The IGB was removed 6 months later. All patients were followed for a minimum period of 6–12 months. The insertion of a gastric balloon gives good results in the reduction of weight in all five cases; it seems that the use of gastric balloon insertion in obese patients is an effective technique for weight loss.
Keywords: Endoscopy, gastric balloon, insertion, methylene blue, obesity
|How to cite this article:|
Jain SM, Joshi MA. Endoscopy-guided intragastric balloon. MGM J Med Sci 2020;7:225-9
| Introduction|| |
Obesity is a major cause of morbidity and mortality worldwide. It is associated with functional impairments and comorbidities, including hypertension, cardiovascular disease, diabetes mellitus, metabolic disorders, arthrosis, and obstructive sleep apnea. The incidence of obesity at all ages is on the rise in developing countries including India. Despite advances, obesity management remains challenging and the availability of safe and effective weight loss therapies is limited. Diet and exercise often do not produce significant and sustained weight loss. While bariatric surgery has proven efficacy in treating morbidly obese patients, it is not widely used in class I obese population (body mass index [BMI] 30 to 34.9 kg/m2), due to its invasiveness, cost, and potentially lifelong side effects.
Intragastric balloon (IGB), a device that is introduced by endoscopy, is used to obtain weight loss for temporary obesity management and is steadily gaining popularity among the medical treatments available for obesity. It relies on a soft, saline-filled balloon placed in the stomach to promote the feeling of satiety and restriction. The weight loss mechanism of IGB therapy is restrictive. Any balloon with a volume of 400 mL or greater can induce satiety. Another possible mechanism of action that may also contribute to weight loss is by delaying gastric emptying. IGB is advised before any planned surgery in morbidly obese and before obesity surgery, to improve comorbidities and minimize the risk of surgery. Moreover, it is used for super obese patients who are unfit for obesity surgery. Their efficacy and safety are reinforced by a growing body of evidence obtained around the globe.
IGBs are now considered one of the safest and most effective medical procedures for weight reduction. In addition, the reduced potential for side effects and low invasiveness (compared to bariatric surgeries) are important considerations. Here, we report three cases of obese patients, that is, three women and two men, their weight was managed through the insertion of a saline-filled IGB and gives good results in the reduction of weight.
| Case reports|| |
This case series enrolled a total five cases of obese patients (three women and two men), who selected IGB method for weight loss and who did not desire to undergo surgery due to fear of complications or mortality. A detailed history including the age of the onset of obesity, dietary habits, the previous trial of weight reduction, and history of obesity comorbidity was taken. After obtaining specific written informed consent, all five patients underwent complete physical examination, anthropometry (body weight [BW], BMI, percentage of BW loss, and fat mass), blood pressure measurement, and determination of serum triglycerides, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, glucose, and liver enzymes (ALT, GGT) at baseline, 6 months (time of IGB removal), and 6–12 months after IGB removal. Successful weight loss was defined as 20%–50% weight loss after 6–12 months.
A 47-year-old obese man presented to our hospital with a BMI of 35 kg/m2 and BW of 113 kg and also with severe obesity-related disorders who had failed to achieve weight loss with an adequate weight loss program for 2 years. He was advised to manage weight by inserting a saline-filled gastric balloon at our hospital. Balloons were sited endoscopically under general anesthetic and inflated with 500-mL saline stained with methylene blue to alert patients to balloon deflation. An antiemetic regimen of dexamethasone (single dose), cyclizine, ondansetron, and buscapan was given intravenously initially and orally when tolerating fluids. He was discharged the following day on antiemetics and antispasmodics. Lansoprazole was prescribed while the balloon was in situ to prevent gastric erosion/ulceration and to protect the balloon. The patient was advised a fully liquid diet in the first-week post insertion with semi-solids in the second week and a normal, healthy diet by week 3. Calories were not restricted to a set number. No signs of balloon deflation were seen, and the urine appears normal color. He had lost 15% of his BW during the first 6 months. The IGB was removed 6 months later. A patient was followed for a minimum period of 6–12 months. The weight of the patient before balloon insertion was 113 kg and after 1 year of balloon insertion, the weight of the patient was 98 kg. Thus, the insertion of the balloon gives good results in the reduction of weight in this case.
A male patient of age 18 years with BMI 49 kg/m2 (class III obesity) and BW of 140.6 kg was presented to our hospital which was a complication of morbid obesity, needing a CPAP ventilator of night. He had made several attempts to lose weight, including numerous types of diet and medication, with only temporary and minimal success. After discussing the therapeutic options and excluding any contraindications, medisil pure silicon IGB was positioned after ruling out pyloric outlet obstruction and hiatal hernia by prior endoscopy. The balloon was positioned under endoscopy control and inflated with 500 mL of methylene blue-stained normal saline. The patient tolerated the procedure well. He was advised to nil by mouth for 2h before and after endoscopy and in the evening patient was advised a fully liquid diet on the same day of balloon insertion. On the next day, the patient complained of nausea and vomiting. Six months after IGB placement, we removed the balloon but followed the patient for another 6 months. Before balloon insertion, the weight of the patient was 140.6 kg and 1 year after balloon insertion weight was reduced to 119 kg.
A 38-year-old woman with a BMI of 34 kg/m2 (class I obesity) and a BW of 108 kg was presented in our hospital for reducing the BW. The IGB was placed with the patient under anesthesiologist administered propofol sedation. A complete upper gastrointestinal endoscopy was previously performed to exclude abnormalities. The balloon was inserted into the gastric body collapsed within a specially designed sheath, as presented in the commercially available pack. Then, the endoscope was reinserted, and the balloon was inflated under direct endoscopic vision with saline (600 mL) + methylene blue (5 mL) solution. After the procedure, the patients were kept in the recovery room for 2h for observation and for symptom control. Once she could tolerate a liquid diet, she was discharged medicated with proton pump inhibitors, which were indicated to maintain until removal of the IGB, and with antiemetic agents for 1 week. No signs of balloon deflation were seen. Patient complained about diarrhea and abdominal pain on the next postoperative day.
A patient was advised to follow a fully liquid diet for the first 4 weeks and a soft diet was gradually introduced thereafter. During the 6 months of treatment, a balanced diet with 1100 kcal/day and 20% protein was prescribed by the nutritionist (regardless of the BMI). The patient was followed twice a week for the first week, then at the end of the first month, and finally at 3 and 6 months. During the follow-up visits with the nutritionist, the nutrition plan and the weight control were evaluated, and nutritional education was reinforced. The IGB was removed 6 months later under endoscopic control using the IGB removal kit. Then, the patient was followed on an outpatient basis by the nutritionist for a period of 6–12 months after the placement of the IGB. The weight of patients before balloon insertion was 108 kg, which was reduced to 91 kg 1 year after balloon insertion.
A 41-year-old woman with a BMI of 38 kg/m2 (class II obesity) and a BW of 110 kg was presented in our hospital to reduce BW. IGB was placed endoscopically in the stomach under deep sedation with propofol. After IGB insertion into the gastric fundus, the balloon was inflated under direct vision with methylene blue-added 700 mL saline. The patient was allowed to go home within a few hours after balloon placement and given oral antiemetics (metoclopramide 10 mg tds), anti-spasmodic (hyoscine-N-butyl bromide 10 mg tds) and proton pump inhibitor (lansoprazole 30 mg daily). A patient was given a diet of 1000 kcal/day by a dietician. On the next day patient complained with nausea and vomiting which is a common side effect of IGB insertion. Six months after IGB placement, we removed the balloon but followed the patient for another 6 months. Before balloon insertion, the weight of the patient was 110 kg and 1 year after balloon insertion weight was reduced to 89 kg.
A female patient of age 22 years with BMI 40 kg/m2 (class III obesity) and BW of 115 kg was presented to our hospital which was a complication of morbid obesity. She was advised to manage weight by inserting an IGB. A medisil pure silicon IGB was positioned after ruling out pyloric outlet obstruction and hiatal hernia by prior endoscopy. The balloon was positioned under endoscopy guidance and inflated with 500 mL of methylene blue-stained normal saline. The patient tolerated the procedure well. She was advised to nil by mouth for 2h before and after endoscopy and in the evening patient was advised a fully liquid diet on the same day of balloon insertion. On the next day, the patient was presented with vomiting and abdominal pain. Six months after IGB placement, we removed the balloon but followed the patient for another 6 months. Before balloon insertion, the weight of the patient was 115 kg, and 1 year after balloon insertion weight was reduced to 99 kg.
In all five cases, most of the weight loss occurred in the first 2 months (75% of total lost weight). In the third and fourth months, the patients succeeded in losing only 25% of the total lost weight. In the last 2 months (5th and 6th months), almost all patients ceased to lose weight. Hence, IGB is safe and effective in total weight management.
The exclusion criteria of the study included any situation that could increase the risks related to IGB insertion, such as a Large hiatus hernia >5 cm, active ulcers, previous surgery, tumors, oropharyngeal abnormalities, varices, coagulopathy, psychological disorders, use of anticoagulants, and anti-inflammatory drugs.
| Discussion|| |
Obesity is a serious disease and is increasing at an alarming rate throughout the world. The rising burden of obesity is a threat to both developed and developing countries. According to the World Health Organization in 2008, over 1.4 billion adults were overweight and more than half a billion were obese. The recent ICMR-INDIAB study conducted in three states namely Tamil Nadu, Maharashtra, and Jharkhand and one Union Territory Chandigarh of India found that the prevalence of generalized obesity ranged from 11.8% to 33.6% among the residents. Comparison of two major studies conducted by the National Family Health Survey (NFHS-2) in 1998–1999 and NFHS-3 in 2005–2006 shows that the prevalence of obesity among Indian women has elevated from 10.6% to 12.6%. The Chennai Urban-Rural Epidemiology Study determined that the age-standardized prevalence of generalized obesity was 45.9% (95% confidence interval [CI]: 43.9%–47.9%).
Bariatric surgery is the most fruitful, sustainable long-term therapeutic option for obesity but this surgery has major drawbacks such as difficult accessibility, cost, patient’s refusal or nonpreference, morbidity, and mortality. Therefore, there is a continuous search for novel, safe, and effective methods for weight loss, like endoscopic approaches, including IGB. The use of an endoscopically placed IGB to treat obesity was first described in the early 1980s and IGBs of one type or another have been used in clinical practice ever since., Currently, two types of balloons are available; the air-filled and the saline-filled. Caglar et al. reported the use of a saline-filled gastric balloon gives more good results in weight loss than an air-filled gastric balloon. An air-filled polyurethane device, approved by the Food and Drug Administration (FDA) in 1985, was later withdrawn due to a lack of supportive efficacy data and a high rate of serious complications. Now, the new generation of IGBs is made of silicone, implanted in the stomach endoscopically, and filled with a saline solution up to 960 mL and methylene blue through a self-sealing valve. The methylene blue is added because it changes the color of the urine if the balloon ruptures., The outpatient procedure takes less than 20min, and the device is removed 6 months later.
Beyond this period the acidic gastric content weakens the balloon material and may cause its spontaneous, complete, or partial deflation. Subsequently, the balloon may migrate through the pylorus into the small bowel and lead to intestinal obstruction, especially in patients who have had previous abdominal surgery. This condition requires urgent laparotomy and surgical balloon removal. However, there is limited evidence in the literature regarding the durability and efficacy of IGBs, the available studies having certain limitations; it is recommended that an IGB not be left in place for more than 6 months.,, However, that time frame is not absolute, because most reported cases of IGB-induced perforation has occurred during the first 6 months after the insertion of the device.
The most common side effects associated with the use of those IGBs were nausea, vomiting, diarrhea, and abdominal pain, difficulty in inflating or deflating the balloon, unexpected deflation, and migration, any of which could lead to serious complications.,, In the present series, all the patients complained of either one of the side effects of nausea, vomiting, diarrhea and abdominal pain on the next day of discharge. In all five cases, no signs of balloon deflation were seen. Deflation is a rare, but potentially life-threatening complication of IGBs due to the risk of bowel obstruction. To address this concern, specialists organized a conference to determine the ideal characteristics of safe and effective IGB practice. The recommended procedure is one in which the IGB is introduced endoscopically, after which it is filled with 400–700 mL of saline and methylene blue; the methylene blue is added because it changes the color of the urine if the balloon ruptures., The saline in the balloons is tinted blue which acts as an indicator. If you notice your urine is blue or green, you should immediately contact your doctor and the patient will immediately take for endoscopy and balloon extraction is done. In our five cases, there was no color change in urine observed.
According to Percival, all saline-filled gastric balloons increase the weight loss and being maximum in the first 6 months after balloon insertion, also according to Ponce et al., the volume of injected saline of the re-inflatable gastric balloon affects the results of weight reduction. In our case series, in all five cases, the balloons were sited endoscopically under general anesthetic and inflated with saline + methylene blue solution but the volume of saline and methylene blue used in each case was different. All patients were followed for a minimum period of 6–12 months. No symptoms were identified during the clinic follow-up and patients have had a normal upper gastrointestinal exam, with no scars. Thus, in this case, series the insertion of a gastric balloon gives good results in a reduction of weight in all three cases; it seems that the use of saline-filled gastric balloon insertion in obese patients is an effective technique for weight loss as similar to previous studies.,,
Adverse events rates following Orbera IGB placement showed pooled incidences of pain (33.7%) and nausea (29%) as common adverse side effects. The incidence of GERD, gastric ulcers, and balloon migration was 18.3%, 2%, and 1.4%, respectively. Serious adverse events with the Orbera balloon are uncommon, with prevalences of small bowel obstruction, perforation, and death as 0.3%, 0.1%, and 0.08%, respectively. Similarly, the REDUCE pivotal trial (n = 264), which evaluated the efficacy and safety of the ReShape Duo IGB showed that symptoms such as nausea, abdominal pain, and vomiting was common but decreased rapidly with medical management. New emerging technology trends in endoscopic treatment for obesity require an extensive and meticulous research plan to promote finding and recognize their optimal role in managing obese patients and their applications for clinical practice
| Conclusion|| |
The treatment of obesity by saline filled intra-gastric balloons insertion/placement is a safe and effective procedure for weight loss. Careful patient follow-up is of primary importance to avoid complications and to support the efficacy of the treatment. One year of follow-up cannot be considered “long-term,” but these results are encouraging. There is a need to study our experience with a larger population of patients who have had this device inserted.
Intra gastric balloon should be recommended to patients who have previously tried traditional methods of weight reduction which have failed. The general recommendation for most intra-gastric balloons is that it should be removed in 6 months, to reduce complications.
The authors would like to acknowledge Lokmanya Tilak Medical College and General Hospital, Sion, Mumbai, India for providing necessary facility. The authors also would like to thank Ms. Trupti Bobade for her assistance extended in writing the manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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