1.
Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).
Caiazzo, R, Branche, J, Raverdy, V, Czernichow, S, Carette, C, Robert, M, Disse, E, Barthet, M, Cariou, B, Msika, S, et al
Annals of surgery. 2020;(5):696-702
Abstract
OBJECTIVE The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.
2.
Laparoscopic duodenojejunal bypass with sleeve gastrectomy: preliminary results of a prospective series from India.
Raj, PP, Kumaravel, R, Chandramaliteeswaran, C, Vaithiswaran, V, Palanivelu, C
Surgical endoscopy. 2012;(3):688-92
Abstract
BACKGROUND Bariatric surgeries are now redefined as metabolic surgeries given the excellent resolution of metabolic derangements accompanying obesity. Duodenojejunal bypass (DJB) is a novel metabolic surgery based on foregut hypothesis. Reports describe DJB as a stand-alone procedure for the treatment of diabetes in nonobese subjects. For obese subjects, DJB is combined with sleeve gastrectomy. This combination of DJB and sleeve gastrectomy is proposed as an ideal alternative to Roux-en-Y gastric bypass (RYGB) with these advantages: (1) easy postoperative endoscopic surveillance, (2) preservation of the pyloric mechanism, which prevents dumping syndrome, and (3) reduced alimentary limb tension. This study aimed to analyze the short-term outcomes of laparoscopic DJB with sleeve gastrectomy for morbidly obese patients. METHODS At our institution, 38 patients who underwent laparoscopic DJB with sleeve gastrectomy were followed up. The inclusion criteria for the study were according to the Asian Pacific Bariatric Surgery Society guidelines. Sleeve gastrectomy was performed over a 36-Fr bougie, with the first part of the duodenum mobilized and transected. The jejunum was divided 50 cm distal to duodenojejunal flexure. A 75- to 150-cm alimentary limb was fashioned and brought in a retrocolic manner. End-to-end hand-sewn duodenojejunostomy was performed. Intestinal continuity was restored with a stapled jejunojejunostomy, and mesenteric rents were closed. RESULTS The study population consisted of 38 patients (15 men and 23 women) ranging in age from 31 to 48 years. During a mean follow-up period of 17 months, the excess body weight loss was 72%, with a 92% resolution of diabetes. One patient presented with internal herniation through the retrocolic window 1 month after the operation and was managed surgically without any complication. No other minor or major complications occurred, and there was no mortality. CONCLUSION Laparoscopic DJB with sleeve gastrectomy is safe and effective in achieving durable weight loss and excellent resolution of comorbidities. Long-term follow-up studies are needed.
3.
Clinical improvement after duodenojejunal bypass for nonobese type 2 diabetes despite minimal improvement in glycemic homeostasis.
Ferzli, GS, Dominique, E, Ciaglia, M, Bluth, MH, Gonzalez, A, Fingerhut, A
World journal of surgery. 2009;(5):972-9
Abstract
BACKGROUND Glycemic control of type 2 diabetes mellitus (T2DM) remains a dilemma to physicians. Although gastric bypass surgery undertaken for morbid obesity has been shown to resolve this disease well, data on the effectiveness of duodenojejunal bypass in improving or resolving T2DM and the metabolic syndrome (MS), especially in nonobese patients are scarce. This study was intended to evaluate the clinical effects of laparoscopic duodenojejunal bypass (LDJB) in patients with T2DM and a body mass index of <35 kg/m(2). METHODS We conducted a 12-month prospective study on the changes in glucose homeostasis and the MS in seven T2DM subjects undergoing LDJB with similar DM duration, type of DM treatment, and glycemic control. Laboratory values including glycosylated hemoglobin A (HbA1c), fasting blood glucose, cholesterol, triglyceride, and C-peptide were followed throughout the 12 months. Serum levels of gastric inhibitory peptide and ghrelin were followed for 1 month. Serum levels of gastrin and glucagon-like peptide were followed for 3 months. RESULTS At 12 months after surgery, all subjects consistently felt relief from fatigue, pain and/or numbness in the extremities, polyuria, and polydypsia. Clinical resolution was obtained for one patient, and the preoperative diabetic medication requirements decreased for most of the other patients. The subjects demonstrated an overall improved HbA1c (from 9.4% to 8.5%) and fasting blood glucose level (from 209 to 154 mg/dl). Although the change in fasting blood glucose approached statistical significance, these measures of glucose homeostasis did not achieve significance. Cholesterol and triglycerides increased slightly, and C-peptide decreased slightly over 1 year. These changes were not statistically significant. CONCLUSIONS Although this is a small series, our data show that at 12 months after surgery, clinical improvement was obvious in all of our seven patients, but LDJB may not be effective at inducing remission of T2DM and the MS in certain patients undergoing this operation. This suggests that larger patient studies should be conducted, before concluding that surgery may offer clinical and biochemical resolution to a disease once treated only medically. Longer follow-up is required for better evaluation.