OBES SURG (2009) 19:307–312DOI 10.1007/s11695-008-9759-5 Laparoscopic DuodenalJejunal Exclusionin the Treatment of Type 2 Diabetes Mellitusin Patients with BMI < 30 kg/m2 (LBMI) Almino C. Ramos & Manoel P. Galvão Neto &Yglésio Moyses de Souza & Manoela Galvão &Abel H. Murakami & Andrey C. Silva &Edwin G. Canseco & Raúl Santamaría &Trino A. Zambrano Received: 30 May 2008 / Accepted: 15 October 2008 / Published online: 6 November 2008 # Springer Science + Business Media, LLC 2008 Results There was a BMI decrease up to the third month Background The association between medical and dietetic– and a weight stabilization between the third and sixth behavioral treatments of type 2 diabetes mellitus (T2DM) months. There was a significant reduction in fasting has demonstrated to have variable results. The surgical glycemia (43.8%) and HbA1c (22.8%) up to the sixth treatment of T2DM is justifiable after the observation of a month (p<0.001). C-peptide did not show any significant successful glycemic control in patients submitted to Roux- alteration until the third month, although there was a en-Y gastric bypass and biliopancreatic diversion. Experi- considerable increase (25%) between the third and the sixth ments have shown an important role of the proximal months (p < 0.001). Only two patients were on oral intestine in glycemia decrease and diabetes control.
Methods Twenty diabetic patients underwent laparoscopic Conclusions Preliminary results have shown an important duodenal–jejunal exclusion. The variables studied were effect of the laparoscopic duodenal–jejunal exclusion in the body mass index (BMI), fasting glycemia, glycosylated treatment of T2DM. Studies with longer follow-up and a hemoglobin (HbA1c), and C-peptide, in the preoperative larger number of patients are necessary to better define the role of this new and promising procedure.
Dr. Almino Ramos and Dr. Manoel P. Galvão Neto are international Keywords Diabetes mellitus . Duodenal–jejunal exclusion .
consultants for Ethicon Endo-Surgery® and GI Dynamics®.
A. C. Ramos Y. M. de Souza M. Galvão A. H. Murakami A. C. Silva E. G. CansecoGastrointestinal, Bariatric and Metabolic Surgery,Gastro Obeso Center, Diabetes mellitus affects nearly 150 million people all over the world. This number may double by 2025 []. In the Gastrointestinal, Bariatric and Metabolic Endoscopy,Gastro Obeso Center, USA, it is the leading cause of blindness, chronic renal insufficiency, and amputations, multiplying by three therisks of heart diseases and by two the risks of a stroke. The annual health system expenditures amount to 100 billion Division of Bariatric and Metabolic Surgery, San Obeso Center,Guayaquil, GU, Ecuador American dollars It is type 2 diabetes mellitus (T2DM)that predominates in about 90% of patients, usually associated with intolerance to glucose and overweight.
Rua Barata Ribeiro, 237-cj. 83/84, Cerqueira Cesar, The treatment of T2DM in the past few years has been São Paulo, SP CEP: 01308-000, Brazile-mail: based upon a combination of dietetic–behavioral proce- dures and medical therapy with oral hypoglycemiants and, shears, Ethicon Endo-Surgery, Cincinnati, OH, USA), in more severe cases, insulinotherapy with variable success preserving the gastroepiploic vessels until the head of the rates []. The large variability in clinical treatment results pancreas is reached. Once in the retrocavity, the dissection and the growing economic impact of the DM treatment and is extended to the lesser curvature for freeing the first its complications worldwide justify the search for new and duodenal portion (about 2 cm distal to the pylorus), where a efficient treatment methods, whether clinical or surgical. In 45-mm linear stapler (ETS-Flex Endoscopic Articulating the past two decades, with the advancement of bariatric Linear Cutter, Ethicon Endo-Surgery) with a vascular white surgery and the observation of a successful glycemia load is fired (Fig. ). Pyloric artery ligation is always control in patients who underwent Roux-en-Y gastric performed to achieve a tension-free duodenojejunostomy.
bypass and biliopancreatic diversion (Scopinaro & Duode- A jejunal omega isoperistaltic loop 200 cm from the nal Switch), many groups have been trying to elucidate the Treitz ligament is shown in an antecolic isoperistaltic mechanisms associated with glycemia control [–]. At fashion. A 45-mm linear stapler (vascular) performs the first, it was thought that glycemia stabilization would be a terminolateral duodenojejunostomy. The stapled hole is direct consequence of weight loss induced by surgery.
closed by a layer of continuous suture with PDS 3.0® Rubino et al. carried out a study with non-obese diabetic rats which underwent duodenal–jejunal exclusion, having By mobilizing the alimentary limb on the surgeon’s left found a significant glycemia decrease in about 40% of them side, a side-to-side enteroenterostomy is performed with a and an improvement in tests of glucose oral tolerance 45-mm vascular stapler 100 cm distal from the duodeno- (better result than clinical treatment with rosiglitazone).
jejunostomy. Roux-en-Y reconstruction is completed Independent from any ponderable weight loss, this effect through stapling between the duodenojejunostomy and the was confirmed within a 3-week postoperative observation enteroenterostomy with a 45-mm vascular stapler (Fig. ]. In this setting, a study protocol of 20 patients with Mesenteric defects are closed with an Ethibond® 3.0 low body mass index (LBMI) was designed in which they running suture. A tubolaminar drain is left next to the underwent laparoscopic duodenal–jejunal exclusion, under duodenojejunostomy until the seventh postoperative day.
informed consent, aiming to control glycemia and to A hypoglycemic/hypolipidemic diet is started on the first improve the conditions associated with T2DM.
postoperative day. Patients are stimulated to walk, beingdismissed from the hospital on the second postoperativeday. Dosages of fasting glycemia, HbA1c, C-peptide, and BMI calculation are taken at postoperative days 30, 90, and180. Glycemic control at home is maintained as in the From August 2006 to October 2007, we started aprospective study in patients with BMI between 20 and30 kg/m2, aged between 18 and 60 years old, with diabetesbeing diagnosed later than two and earlier than 8 years,without a history of insulinotherapy and with C-peptidelevels >1.0 ng/ml. All patients were explained the risks andbenefits of this new technique and have provided informedconsent term approved by the local Institutional ReviewBoard.
Patients taking hypoglycemiants different from metfor- min, glimepiride, and glitazones, with a previous history ofdifficult glycemic control or ketoneacidosis, with a weightloss of more than 5 kg in the last 3 months or with HbA1c>11% were excluded from this protocol.
Positioning of patient, surgical team, and punctures aresimilar to that in a five-trocar antireflux procedure. Thegreater omentum is divided at the greater gastric curvaturewith the use of a harmonic scalpel (Harmonic ACE 5 mm Fig. 1 Transection of the first duodenal portion sary. It was necessary to use the logarithmic transformationin the variable fasting glycemia. Values of p<0.05 wereconsidered significant []. The statistical analysis weremade by the software “Statistical Package for SocialSciences” version 11.0 for Windows.
Twenty patients were included in the study (11 men and ninewomen). Mean age was 43 (29–60) years old. The meanT2DM diagnosis time was 5.3 (2–8) years. Mean preoperativeBMI was 27.1 (25–30). Mean BMI in the third and sixthpostoperative months were respectively 25 (22–29) and 24.4(20.2–28.3). A statistically significant difference was ob-served between BMI in the preoperative period and in thethird month (p<0.001). However, there was no differencebetween the third and the sixth months (p=0.732), showing aweight loss stabilization, around 7.8% below the initialweight (Fig. Preoperative fasting glycemia level was 171.3 (127–242).
After the third and the sixth postoperative months, there was a Fig. 2 Creation of the duodenoenterostomy 200 cm from the Treitz reduction of 37.5% and 43.8% (p<0.001), respectively.
Comparing the third and the sixth postoperative months,there was a significant difference (p=0.047; Fig. ).
Concerning HbA1c, the mean value in the preoperative 1c, fasting glycemia, and C-peptide data were checked using analysis of variance, together with multiple period was 8.8% (7.5–10.2). There was a decrease to 7.8 comparisons through the Bonferroni method when neces- Fig. 3 Formation of the enteroenterostomy, 100 cm from the previous Fig. 4 BMI evolution up to the sixth postoperative month. PRE anastomosis and the jejunal section for the final bypass positioning preoperative data, 3M 3 months, 6M 6 months Fig. 7 C-peptide up to the sixth postoperative month. C PEP C- Fig. 5 Fasting glycemia up to the sixth postoperative month. PRE peptide, PRE preoperative data, 3M 3 months, 6M 6 months preoperative data, 3M 3 months, 6M 6 months (6.7–9.6) and 6.8 (5.8–7.9) in the third and sixth postop- and 2.5 (1.7–3.2). However, there was no statistical erative months, respectively (p<0.00l; Fig. significance up to the third month (p=0.247). In the sixth The mean value of C-peptide levels in the preoperative month, there was an increase of 25% in the C-peptide levels period was 2.0 ng/ml (1.2–3.4). In the third and sixth (p<0.001; Fig. ). Results are summarized in Table .
postoperative months, there was an increase to 2.1 (1.5–2.9) Only two patients (10%) included in this study were kept on oral medication (metformin) after the sixth postoperativemonth. Patients are still on clinical follow-up aiming along-term analysis. There have been no postoperativecomplications, such as fistulae or abscesses in this groupof patients. No mortality was observed.
Table 1 Comparative results between BMI, HbA1c, glycemia, and C-peptide in different collection moments PRE > 3M (p<0.001a)PRE > 6M (p<0.001a)3M = 6M (p=0.732a) PRE > 3M (p<0.001a)PRE > 6M (p<0.001a)3M > 6M (p<0.001a) PRE > 3M (p<0.001a)PRE > 6M (p<0.001a)3M > 6M (p=0.047a) PRE = 3M (p=0.848a)PRE < 6M (p<0.001a)3M < 6M (p<0.001a) Fig. 6 HbA1c up to the sixth postoperative month. PRE preoperative PRE preoperative data, 3M 3 months, 6M 6 months in the regulation of glucose metabolism , TheHbA1c reduction was the result of a better glycemic control In recent years, some procedures have been proposed in the and the C-peptide increase was the result of improvement literature for the treatment of T2DM in non-obese and of the pancreatic function, probably as a consequence of obese patients, as the duodenal–jejunal exclusion and the ileal interposition ]. We have chosen the duodenal– The idea of bypassing the duodenum and proximal jejunal exclusion based on the consistent results on jejunum as a means of achieving glycemic control was first glycemia control reported by Rubino et al. in an experi- developed in animal models [, ]. This concept has mental protocol in Goto–Kakizaki non-obese diabetic rats evolved leading to the pioneers well-succeeded attempts of The option for creating a biliopancreatic limb ranging surgical ] and endoscopic ] duodenal–jejunal exclu- 200 cm from Treitz and an alimentary limb of 100 cm was sions. In the former study [], which included two based in the literature data [and our group’s experience patients, by the fifth week after surgery, both were in bariatric surgery with the Roux-en-Y gastric bypass in euglycemic and free of all antidiabetic medications. The morbidly obese patients who also had hyperlipidemia and HbA1c levels were <6% at the last follow-up visit, 9 months T2DM or glucose intolerance. We have observed a postoperatively. In the latter trial [glycemia control reduction in blood levels of glucose and cholesterol and occurred already 24 h after the initial procedure. De Paula et the resolution of T2DM in most of our cases (unpublished al. proposed a procedure combining an ileal interposition data). The choice for the laparoscopic method was due to its with sleeve gastrectomy in the treatment of T2DM. An benefits in terms of postoperative recovery, surgical important reduction in antidiabetic medications was ob- served. Nearly 87% of the patients permanently discontinued The inferential results showed that the BMI behavior preoperative oral hypoglycemic agents, insulin, or both. A (p<0.001), HbA1c (p<0.001), fasting glycemia (p<0.001), rapid normalization of fasting plasma glucose was achieved and C-peptide (p<0.001) are not statistically the same in by 29% of the patients on the first 2 weeks. However, it is a the different moments of postoperative follow-up. We technically challenging procedure, with major morbidity and verified a weight loss of approximately 7.8% of the total mortality rates of 10.3% and 2.6%, respectively [].
body weight up to the third month and stabilization from Generally, the goals to be reached in the clinical the third to the sixth months. There was an important treatment of T2DM are a fasting glycemia around 100– decrease in fasting glycemia up to the third month, 110 mg/dl and HbA1c at the most 1% above the upper limit followed by a lower reduction after the sixth month. The of the reference value ]. In the present study, the reduction of HbA1c levels was more stable, 11.4% and duodenal–jejunal exclusion was efficient by achieving these 22.8% in the third and the sixth postoperative months, goals. Despite having no clinical randomization or sample respectively. C-peptide levels increased in the sixth month pairing for comparison with a group of patients submitted dosage, probably reflecting a slower recovery of the to clinical treatment in the same institution, the present pancreatic function and insulinic activity in the postopera- study showed a remarkable hypoglycemiant effect of laparoscopic duodenal–jejunal exclusion in the treatment Six months after the duodenal–jejunal exclusion, only 10% of the patients were still taking oral hypoglycemiants.
One of those has had the diagnosis of T2DM for 8 years,the longest in our series. The other patient, although after only 4 years of his T2DM diagnosis, showed no improve-ment in the C-peptide levels, demonstrating a lack of The laparoscopic duodenal–jejunal exclusion is a safe improvement in insulinic secretion. Cohen et al. pointed procedure with low postoperative complication rates and the better response to surgery in a subset of patients an incretinic effect, shown through the reduction of with shorter disease time and higher pre-operative levels of glycemia and HbA1c and the increase of C-peptide secretion in a subset of patients. Further studies with larger Concerning the association between weight loss and samples, randomization, and longer follow-up are necessary glycemic reduction and the improvement in the levels of to clarify its role in the treatment of T2DM.
HbA1c and C-peptide, it can be said that weight loss andglycemic reduction were combined events up to the thirdmonth. However, there was no combination up to the sixth month, showing a possible hypoglycemiant effect throughthe increase of incretins. Many publications have pointed 1. Zimmet P, Alberti K, Shaw J. Global and societal implications of the importance of these gut hormones (GLP-1, PYY, GIP) the diabetes epidemic. Nature 2001;414:782–7.
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