(The following is my revision of Chris Hull's work to fit my specific appeal)
Research Appeal for Gastric Surgery
I would like to address the claim that the biliopancreatic diversion with duodenal switch (BPD/DS) procedure is "investigational." First, I would like to briefly discuss the disadvantages of the alternatives that were recommended by the National Institute of Health in 1991.
Vertical-Banded Gastrectomy: Not an effective procedure
The Vertical-Banded Gastrectomy (VBG) suffers from the problem of staple line breakdown as well as poor behavior reinforcement. The extremely small opening to the stomach, which is restricted with a silastic ring, allows high calorie beverages and sweets to be eaten, but makes more nourishing foods difficult to eat. In his 10-year follow up study at the Mayo Clinic, Balsiger reports "only 26% of the VBG patients have maintained a weight loss of at least 50% of excess body weight" (Gastrointest Surg 2000). In addition he reports that "Vomiting one or more times per week continues to occur in 21% and heartburn in 14%". Balsiger also states, "the anatomy of vertical banded gastroplasty appears to predispose to symptoms of gastroesophageal reflux disease". Balsiger concludes with "Thus the VBG is not an effective, durable bariatric operation".
Wyss studied 100 patients at 5 years after their VBG operation found that 11% no longer had the band, 24% failed to lose even 40% of their excess weight, and 22% would not choose to repeat the operation if given a choice. Frequent vomiting was reported in 49% of the cases, constipation in 20%, gastritis is 30% of all patients. Metabolic problems occurred in 12.3% of the patients that successfully lost more than 40% of their excess weight. "The majority of our patients could no longer eat read meat (87%), … other types of food also became unacceptable." Wyss concludes that "persistent vomiting after several years, persistent esophagitis and gastritis need lifelong medical supervision" (Obes Surg 1995).
Roux-en-Y Gastric Bypass: The "Gold Standard" is getting tarnished
The other approved procedure -- the Roux-en-Y (RNY) (and the one performed at UCLA) -- has a number of significant disadvantages. The chief problem with the RNY is its high failure rate. MacLean found in his 5-year longitudinal study that nearly half of the super-obese patients were a failure with the RNY (Ann Surg 2000). According to Bloomston only 26% of super obese patients returned to within 50% of their ideal body weight (Obes Surg 1997). Smith found after a seven-year review of 3,855 patients who had the Roux-en-Y, the average weight loss was 35.4 kg (Obes Surg 1995).
Even when a review of the effectiveness of the RNY procedure in the general population (as opposed to just the super obese), long-term studies consistently show weight regain beginning after three years. Excess weight loss decreased to a range of 50-60% at 4-6 years [Oh CH (Obes Surg 1997); Reinhold (J Am Coll Nutr 1994); Smith (Obes Surg, 1995)] and only 47-49% at 10-15 years [Mitchell (Obes Surg 2001); Pories (Ann Surg 1995)]. Mitchell reported that three of his subjects "weighed more at long-term follow-up than before the operation. Wolfel concluded that the RNY failed to provide "adequate or prolonged control of morbid obesity" and that "none of the 1119 patients ever moved out of the category of "morbid obesity" (Eug J Surg 1994).
Even if it weren't for the ineffective weight loss followed by weight regain, additional multiple problems with the RNY make it at best a poor second-choice surgery to the biliopancreatic bypass with duodenal switch. The weightloss that is achieved through the RNY appears to be primarily dependent upon the removal of the pyloric valve, leaving the individual without a regulator of food movement into the small intestine. This results in the well-known phenomena called "dumping syndrome" which can cause an individual to feel sick or even faint. Supporters of the procedure actually refer to this unpleasant side effect as a benefit because it helps the patient form an aversion to sugar.
The extremely small "pouch" (approximately 1 oz) created in the RNY procedure to replace the stomach causes vomiting whenever the patient eats even the slightest amount beyond what the pouch can handle (Mason World J Surg 1998). In addition, the patient cannot eat and drink at the same time. Meat intolerance is reported in the majority of the patients, even seven years after their operation ( Avinoah Surgery 1992). The volume of food that the patient is allowed to consume is so small that it causes severe social problems in restaurants and other social eating occasions. Patients will vomit or get food stuck in their pouch if it is not mashed into the tiniest peaces before swallowing.
An additional problem with the Roux-En-Y is the occurrence of ulcers. Sanyal reports a rate of stenosis and ulceration of 12.5% and 12% respectively (Am J Gastroenterol 1992). MacLean reported, "Stomal ulcer occurred in 16%" (J Am Coll Surg 1997). Wolfel reported a 12% rate of ulceration. Ulceration is practically absent in the BPD/DS procedure.
The complications caused by the RNY procedure are not limited to the first months/years following the surgery. In a recent 13-16 year follow-up of 100 patients, Mitchell states "68.8% (of the patients) reported continued problems with vomiting and 42.7% with "plugging, 42.9% had heartburn and 31.6% reported diarrhea… Eight had died" (Obes Surg 2001). Wolfel in a 10-year follow-up study of transected and stapled gastric bypass along with horizontal gastroplasty, reported a 39% rate of vomiting, a 45% rate of heartburn, and an 18% rate of cramps (Eur J Surg 1994).
Biliopancreatic Diversion with Duodenal Switch: The Platinum Standard
The original Biliopancreatic Diversion procedure introduced in 1979 by Scopinaro used a distal gastrectomy. This procedure will be denoted BPD/DG. In 1989 Hess combined DeMeester's Duodenal Switch procedure with Biliopancreatic Diversion to for the new BPD/DS procedure. The resultant procedure achieved gastric restriction with normal gastric function including the pyloric valve. Marginal ulceration and the dumping syndrome were eliminated. Hess sums up the primary advantages of the BPD/DS procedure: "There is no isolated stomach, no foreign body or band required. There is preservation of the pylorus, no dumping syndrome, no marginal ulcers, and good weight loss" (Obes Surg 1998).
Now, as to the issue of the BPD/DS being claimed to be "investigational". According to Health Net's "Guide to Evidence-Based Medicine" - the "Clinical Practice Guidelines" for physicians, the Biliopancreatic Bypass surgery (BPD) is listed on page 181 as "Designed for the extremely obese individuals (more than 225 percent above ideal body weight), this procedure bypasses a large part of the intestine with a concomitant resection of the excluded part of the stomach." This guideline by Health Net was at least in effect by April 1, 1999; however, in September 2001 I was denied this surgery in spite of the fact that I am more than 300 percent above ideal body weight.
In the Third Edition 2001 of the American Society for Bariatric Surgery, the Biliopancreatic Diversion alone, and the Biliopancreatic diversion with "Duodenal Switch" are both sanctioned surgical weight loss surgeries.
In addition, I will present a brief review of just some of the peer-reviewed literature available to anyone determining whether this is an investigational procedure, demonstrating that that there is sufficient data currently available to substantiate that the Biliopancreatic Bypass Procedure (both BPD/DG and BPD/DS) are effective:
Sugerman reports, "The biliopancreatic diversion has had excellent weight loss results" (Surgery 1993). Deitel reports: "The BPD has produced the most effective and sustained loss of excess weight of any of the operations thus far" (Eur J Gastroenterol Hepatol 1999). Forestieri in discussing the merits of restrictive versus malabsorptive processes notes, "Without a doubt, the BPD gives good results in terms of weight loss and more stability than gastric restriction procedures" (Obes Surg 1999). Hess (Obes Surg 1998) found that after an eight-year period his "super obese" patients (BMI >50) continued to have a weight loss in the 70% excess. Balsiger reports that BPD is "arguably one of the most effective bariatric procedures in inducing and maintaining weight loss" (Med Clin North Am 2000).
Scopinaro reports on the BPD/DG procedure an excess weight loss of 74% at 2 years increasing to 78% at 12 years. Scopinaro also states that the results of the BPD procedure have shown little or no weight regain even out to 18 years (World J Surg 1998). Other reports on BPD/DG yield similar results: Clare reports excess weight loss at 3 years of 77% using a 250 cm alimentary limb, and 71% using equal length bilio and alimentary limbs (Obes Surg 1993). Vassallo and Totte report 79.6% and 76.2% excess weight loss respectively at 3 years (Vassallo Obes Surg 1997; Totte, Obes Surg 1999). Lemmens reports a 69% excess weight loss at 7 years (Obes Surg 1993). Nanni reported 78% excess weight loss at 2 years (Obes Surg 1997).
Reports of the efficacy of BPD/DS are similar. Hess reported excess weight loss of 80% at 2 years and 70% at 8 years (Obes Surg 1998). Marceau also adopted the duodenal switch procedure and reported 73% excess weight loss at 51 months (World J Surg 1998). Baltasar reported excess weight loss of 70.1% at 1 year, 75% at 2 years, 75% at 3 years and 81.2% at 4 years (Obes Surg 2001). Rabkin reported a mean excess weight loss of 73% at 4 years (Obes Surg 1998).
In summary, the BPD/DG and BPD/DS have reported long-term weight loss in the range of 69%-80%. The efficacy of the BPD and BPD/DS procedures cannot be questioned. The BPD/DG and BPD/DS are the most effective procedures for weight loss in existence today.
Safety of the BPD/DS procedure:
Having shown the efficacy, the key remaining question becomes the safety of this procedure.
Operative and late mortality rates of the BPD and BPD/DS procedures are shown to be comparable to other gastric bypass procedures. Deitel reports that with the duodenal switch modification of the BPD: "This procedure is followed by surprisingly few complications, mainly some soft stools and malodorous gas in a minority" (Eur J Gastroenterol Hepatol 1999). Forestieri reports that surgical complications of BPD are comparable to the gastric restrictive procedures. Postoperative complications are reported to be somewhat higher. Forestieri also reports, "BPD, on the other hand, requires careful management only when complications occur, as they do in a limited number of cases. Forestieri concludes, "When all of the above factors are considered these two types of surgeries are both viable options for the treatment of obesity" (Obes Surg 1999).
Liver Failure?
Grimm reports a single case of liver failure and Langdon reports two cases of liver failure. However, Grimm reports that the patient was non-compliant and anorexic. "She refused most oral medications prescribed in hospital, including metronidazole" (Am J Gastroenterol 1992). Langdon reports one patient "refused surgical takedown on multiple occasions" and the other patient "began (drinking) alcohol surreptitiously" (Am J Gastroenterol 1993). And Grimm also reports "the rarity of liver disease after BPD contrasts sharply with the situation after the JI bypass …."
Murr reported a single case of liver failure in a series of 11 patients. However, he also notes that this patient "refused to take the prescribed mineral and vitamin supplementation and never saw her physician" (J Gastrointest Surg 1999).
In his series of 440 patients, Hess reports only a single instance of liver failure, which was associated with multiple organ failure. He concludes, "that liver disease is not a problem with this procedure" (Obes Surg 1998). Baltasar reports on a single case out of a series of 125 patients of liver failure. Scopinaro reported that, with the BPD/DG, 96% of the patients showed elimination or improvement of fatty liver and 4% had no change (World J Surg 1998). And Marceau reports, "BPD, like gastric bypass, improves liver condition" (Eur J Gastroenterol Hepatol 1999). A more recent report by Marceau reports: "After surgery, both liver function and morphology improved to the point where three (out of 12 with preoperative cirrhosis) of them were no longer considered cirrhotic after 10 years (Surg Clin North Am 2001).
Most Traumatic Procedure?
Carmichael touches only briefly on the BPD procedure stating, "This procedure is the most traumatic of all anti-obesity procedures and induces massive metabolic changes" (Postgrad Med J 1999). However, the author neglects to include a single reference or give a single clinical case to substantiate his claim.
Metabolic Complications:
Sugerman reported that with the BPD/DG there are problems with "severe protein-calorie malnutrition, …fat soluble vitamin deficiencies, calcium loss, and iron deficiency." (Surgery 1993). Balsiger echos similar concerns stating that "there are many potential side effects, such as malabsorption of iron, calcium, vitamin B12, and deficiencies in fat soluble vitamins (vitamins A,D,E, and K). Although Sugerman reported no new data to substantiate this claim, I will discuss each of these issues and what the most recent literature reports on them.
Protein Malnutrition (PM):
Scopinaro reports in 1998 that in BPD/DG procedure, increasing the mean gastric volume to 350 ml and increasing the length of the alimentary limb to 300cm reduced the incidence of protein malnutrition to 3%.
Clare shows that modifying Scopinaro's procedure by using equal limb lengths for the alimentary and bilio limbs, but with a 150ml stomach, reduces the rate of protein malnutrition from 8% to 2%. Protein malnutrition generally occurred in the first 6 months, with protein levels returning to near normal levels at 3 years using the equal limb length technique (Obes Surg Aug 1993).
Clare also reported, in an analysis of 16 cases of protein malnutrition out of a series of 504 patients, that "in nearly every case there were multiple factors responsible for the nutritional disturbance, including failure to follow dietary guidelines, failure to take supplements … and indiscriminate use of tobacco alcohol and other drugs.
Totte reports only 2 cases of protein malnutrition in a series of 180 patients, and "in both cases the problem was attributable to a precise cause unrelated to the surgery." One patient "took up drinking, smoking, and cocaine abuse", while the other patient, her twin sister. In both cases a restoration of intestinal continuity left both patients in good general health. A third patient was reversed because "she was not able to reset her self-image of the new slimmer person" (Obes Surg 1999).
Hess reports in 1998 that 8 out of 440 patients (1.8%) undergoing the BPD/DS patients required revisions due to protein malnutrition or excess weight loss. Rather than choosing a fixed limb length, Hess chose to measure the small intestine and make the alimentary limb 40% of the total intestinal length while the common channel was made to be 10%. The mean common channel was increased from 50cm as in Scopinaro to 75cm. (Obes Surg 1998).
Marceau reports that by increasing the common channel from 50cm to 100cm, his yearly revision rate on BPD/DS is only 0.1% per year compared with 1.7% for the BPD/DG procedure. This seventeen-fold reduction in revision rate demonstrates a substantial benefit of the DS procedure over the BPD/DG procedure. Marceau also reported a reduction in hospitalization rate for malnutrition dropped from 1.72%/year with the BPD/DG procedure to 0.93%/year with the BPD/DS procedure (World Journal of Surgery, 1998).
Marceau in reviewing all the literature on BPD and protein malnutrition concludes, "There are differences in surgical techniques that may account for the different results and different interpretations". He goes on to say that "three factors that influence the degree of protein deficiency after BPD (1) the size of the remaining stomach (2) the degree of restriction to nutrient ingestion (3) the initial nutritional state of the patient."
In a modified version of the BPD/DS where temporary gastric restriction was obtained by use of a self-dissolving band, Vassallo reports "At 2 and 3 years follow-up there has been no case of dysproteinemia" (Obes Surg 1997).
Further, protein malnutrition is not unique to the BPD/DS procedure. Kushner reports on a case of severe malnutrition after RNY surgery (J Parenter Enternal Nutr 2000).
To summarize, the modern literature reports a PM rate between 1-3%. PM can be reduced by careful selection of the gastric volume, common channel length, and total alimentary length. In extreme cases, protein malnutrition can be resolved by elongation of the alimentary or common tracts.
Iron Deficiency/Anemia:
Scopinaro reports that anemia appears only in BPD patients with chronic bleeding (menstruation, hemorrhoids, or stomal ulcer). Baltasar reports that oral iron was insufficient in 10% of the female patients, and Hess reports that 9% of his patients required iron supplementation and that "all anemia were correctable with the proper iron or surgical therapy.
Marceau reports that the prevalence of iron deficiencies dropped from 13% preoperatively to 9% postoperatively with the BPD/DS procedure. Laboratory results indicate a slight drop in the mean serum iron levels from 14 umol/L to 13umol/L with an associated drop in the standard deviation. Marceau states "Iron malabsorption is relatively easy to manage medically with oral iron and occasionally intramuscular iron."
Clare reports that the incidence of anemia was reduced from 20% to 10% when the equal limb length technique was used.
Here again, anemia is not unique to the BPD/DS procedure. Halverson reported that "anemia developed on more than one-third of the patients" following the RNY procedure (Am Surg 1986). Brolin reported that "iron deficiency and anemia are potentially serious problems after RYGB" (Gastrointest Surg 1998). Avinoah reported mean serum levels of iron at 73-96 month after surgery to be 10.23 umol/L, which is substantially less than Marceau reported for the BPD/DS procedure. Pories reported an anemia rate of 39%.
In conclusion, the BPD/DS procedure has fewer problems with anemia and iron deficiency than the "gold standard" Roux-en-Y gastric bypass.
Vitamin Deficiency:
Baltasar reports "liposoluble vitamins should be monitored, but so far none of our patients have presented deficits". Marceau reported that the serum levels of vitamin B12 were actually increased slightly in the BPD/DS procedure and the percentage of patients with abnormal serum B12 levels was 3% both pre and post operatively.
Clare reported that the incidence of Vitamin A and D deficiency in a group of patients with equal bilio and alimentary limbs was 0% and 1.4% respectively.
Marceau reports that serum levels of Vitamin A, B12, folic acid, phosphorus and magnesium were unchanged when compared to pre-operative levels.
Once again the problem of vitamin deficiency is not unique to the BPD/DS procedure. Rhode (Obes Surg 1995) and Brolin (Arch Surg 1998) report problems with vitamin B12 deficiency in post RNY patients. Pories also reports a B12 deficiency rate of 40%. Buffington reports vitamin D deficiencies in both post-operative RNY patients as well as pre-operative (Obes Surg 1993).
In conclusion, fat-soluble vitamin deficiencies are rare and easily controlled through oral vitamin supplements. Vitamin B12 deficiency is not a problem whereas it is a problem in the RNY procedure.
Calcium Deficiency/Bone Loss:
Hess reports, "If the patients take their vitamin D and calcium they can maintain the proper levels and in some cases increase their calcium and vitamin D to levels higher than those before surgery."
Scopinaro reports that with the BPD/DG procedure the "older and heavier patients showed a sharp improvement in bone mineralization compared with the preoperative state."
Marceau reports a drop in serum calcium levels from 2.28 (mmol/L) preoperatively to 2.22 (mmol/L postoperatively). The rate of abnormal levels of serum calcium did rise from 4% to 8%. Marceau also states, "the incidence of bone fracture has been 2% per year, which was within normal limits for the general population … further the correlations of lower alkaline phosphate levels and higher phosphate levels with time elapsed after surgery may represent a positive trend." The drop in serum calcium levels about ˝ as large with the BPD/DS procedure compared with the BPD/DG procedure.
Murr reports that two "noncompliant patients" who refused to take supplements developed metabolic bone disease. Murr also noted that for the distal gastric bypass there were no problems with bone demineralization; however, the common channel length was also modified from 50cm to 100cm.
Clare states that "A major factor in the appearance of disturbed bone metabolism is patient non-compliance with respect to diet and nutritional supplements. Fortunately, it responds to aggressive medical treatment" Clare did reported 3 cases out of 504 that required reversal due to disturbed bone metabolism, and "each of these patients had shown very poor compliance with respect to the recommended nutritional supplements."
Marceau recently reported that "10 years after surgery, overall bone density has not changed at hip level and the decrease at spine level was minimal (4%), much less than what was expected for aging alone…. In 33% bone density was increased … and in 15% density decreased more than was expected for ageing alone" (Obes Surg 2001).
Concerns regarding calcium loss and osteoporoses have also been raised for the Roux-en-Y procedure. Ott reports in his bone demineralization study patients 10 years post-operation, "The biochemical pattern suggests the development of metabolic bone disease following RGB" (Obes Surg 1992). In fact the serum alkaline phosphatase level of 121.0 U/L reported by OTT following the RNY procedure is higher than the 105 U/L reported by Marceau following the BPD/DS. Therefore in can be inferred that bone loss may be more severe in the RNY procedure than in the DS.
In conclusion, 10 years after surgery calcium loss appears not to be a problem with the BPD procedure.
Sufficiency of Data Regarding the Biliopancreatic Bypass:
While the BPD/DG procedure is rarely performed in the US, the BPD/DS procedure is frequently performed. Currently there are more than 30 US surgeons performing this procedure with 18 performing it as their primary procedure.
Over a thousand BPD/DS procedures are done each year. The metabolic complication rates have dropped dramatically now that it is common practice to make the alimentary limb length 40-50% of the total intestinal length.
Scopinaro published a paper 3 years ago based on over 2000 patients who underwent the BPD/DG. His report includes following patients for up to 20 years, and he notes that this is the longest longitudinal study on weight-loss surgery ever reported on in the literature. By comparison, Mitchell completed the longest study of the RNY gastric bypass in August of 2001, and it covers only 15 years. Sileo, in his long-term study of the BPD/DG states: "In conclusion, biliopancreatic bypass surgery enables a significant weight loss to be achieved together with an improved glycolipid status without leading to nutritional deficiencies" (Minerva Gastroenterol Dietol 1995).
Since BPD/DS is newer than the BPD/DG procedure, the lengths of the studies are shorter. However, in 1998 Hess reported on a series of 440 patients who underwent BPD/DS followed up to 8 years. Marceau's 1998 report covered 465 patients who underwent BPD/DS a mean of 4.1 years prior to his report. Baltasar 2001 report covers 125 patients who underwent BPD/DS, and Rabkin in 1998 reports on 105 patients who underwent BPD/DS. A recent report by Marceau includes 909 BPD/DS patients studied over 10 years.
By contrast, Dr. Wittgrove's paper on laprascopic RNY cites only 500 cases over a maximum of 5 years, and yet it is considered to be the authoritative study on laprascopic RNY (Obes Surgery 2000).
Regarding the 1991 NIH conference, the conclusions at that time were groundbreaking. However, 10 years of research, as well as research prior to the 1991 conference but published after 1991 conference, have shown that some of the conclusion of that conference need to be revised. Brolin states in 1996 "It seems likely that a consensus panel on the same subject would be worthwhile in the next decade to carefully evaluate such procedures as biliopancreatic bypass …" (Nutrition 1996). Specifically VBG has been shown to be rather ineffective, while BPD/DS has been shown to be safe an extremely effective.
There now exists a large body of evidence to show that the Biliopancreatic Diversion is safe and effective as long as the common channel length is increased to at least 75cm and either the gastric volume or the length of the alimentary limb is increased compared with the original values proposed by Scopinaro (150ml and 250cm respectively).
Several thousand patients have been reported on with follow-ups as long as 20 years. Over the last 3 years there have been numerous peer-reviewed articles showing the long-term safety and efficacy of this procedure. Those that claim otherwise are either confusing the procedure with the old Jejunal-Ileal Bypass or are unaware of the more recent data that provides empirical evidence of the safety of BPD.
In Conclusion
I am a woman who has a BMI of approximately 67-70, fitting quite clearly into the Super-Obese category. Health Net's Clinical Practice Guidelines recommends the "Biliopancreatic Bypass" surgery as the appropriate intervention for individuals "more than 225 percent above ideal weight". I am 300% above ideal weight. The Roux-en-Y surgery is known to have a failure rate of nearly 50%, along with a host of debilitating side effects of the surgery. Even if I were to become a "success" according to statistics of the RNY surgery, I will likely never make it out of the "Super-Obese" category with the RNY. The biliopancreatic bypass surgery is the only viable option and should not be denied to me.