REVIEW ARTICLE
Novel Metabolic Surgery for Type II Diabetes Mellitus: Loop Duodenojejunal Bypass With Sleeve Gastrectomy Chih-Kun Huang, MD,*w Rajat Goel, MD,* Chi-Ming Tai, MD,* Yung-Chieh Yen, PhD,z Vijayraj D. Gohil, MD,* and Xiao-Yan Chen, MDw
Abstract: A total of 22 (14F/8M) patients with a mean age of 50.3 years (range, 33 to 64 y) and a mean body mass index of 28.4 kg/m2 (range, 21.8 to 38.3 kg/m2) underwent loop duodenojejunal bypass with sleeve gastrectomy from October 2011 to March 2012. The mean duration of onset of type 2 diabetes mellitus was 8 years (range, 1 to 20 y). All patients were on oral hypoglycemic agents; 3 (14%) patients were also using insulin. The mean preoperative glycosylated hemoglobin (HbA1c), fasting plasma sugar, and C-peptide levels dropped from 8.6% (range, 7% to 13.2%), 147 mg/dL (range, 108 to 241 mg/dL), and 2.4 ng/mL (range, 0.7 to 4.1 ng/mL) to 6.2% (range, 5.1% to 9.1%), 110 mg/dL (range, 72 to 234 mg/dL), and 1.3 ng/mL (range, 0.6 to 2.8 ng/mL) at 6 months, respectively. At 6 months, 11 (50%) patients showed type 2 diabetes mellitus remission (HbA1c < 6.0%), and 20 (91%) patients achieved HbA1c < 7.0% without medicine. There were no intraoperative or early postoperative complications. Loop duodenojejunal bypass with sleeve gastrectomy is safe, feasible, and shows good efficacy in terms of glycemic control in this preliminary report with short follow-up. Key Words: loop duodenojejunal bypass, obesity, sleeve gastrectomy, type 2 diabetes mellitus
(Surg Laparosc Endosc Percutan Tech 2013;23:481–485)
T
ype 2 diabetes mellitus (T2DM) is a chronic progressive disease and is estimated to affect >300 million people worldwide by the year 2025.1 Surgery has been postulated to achieve remission of T2DM in morbidly obese patients.2–6 In one systemic review and meta-analysis, Roux-en-Y gastric bypass (RYGB), biliopancreatic diversion (BPD), and gastric banding were reported to induce T2DM remission in 83.7%, 98.9%, and 47.9% of patients, respectively.5 Although RYGB and BPD have shown satisfactory remission rates, these procedures are associated with their own set of longterm complications, such as marginal ulcers, internal hernias, dumping syndrome, malnutrition, and, in some cases, mortality. The aim of metabolic surgery is to produce remission of T2DM with more physiological procedures and minimal morbidity and mortality. We have tried to develop loop duodenojejunal bypass with sleeve gastrectomy (LDJB-SG), a new bariatric procedure, as a proposed technique for treatment of T2DM patients to achieve this aim (Fig. 1).
Received for publication December 26, 2012; accepted March 24, 2013. From the *Bariatric & Metabolic International (BMI) Surgery Centre; zDepartment of Psychiatry, E-Da Hospital, Kaohsiung, Taiwan; and wFirst Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. The authors declare no conflicts of interest. Reprints: Chih-Kun Huang, MD, Department of General Surgery, Bariatric & Metabolic International Surgery Centre, E-Da Hospital, 1, E-Da Rd, Jian-Shu Tsuen, Yan-Chau Shiang, Kaohsiung 824, Taiwan (e-mail: [email protected]). Copyright r 2013 by Lippincott Williams & Wilkins
Surg Laparosc Endosc Percutan Tech
MATERIALS AND METHODS The study was conducted with the approval of the ethics committee and institutional review board of the E-Da Hospital and also registered with Current Controlled Trials (ISRCTN63241920). All patients gave written informed consent after understanding the risks and benefits associated with the procedure. Inclusion criteria were: age between 18 and 65 years and poorly controlled T2DM for at least 6 months with a glycosylated hemoglobin (HbA1c) level of Z7.0%. Exclusion criteria were: patients younger than 18 or older than 65 years, those planning pregnancy in next 2 years, type 1 diabetes mellitus, latent autoimmune diabetes in adults, malignancy, debilitating disease, unresolved psychiatric illness, substance abuse, and American Society of Anesthesiologists classification >III. All patients underwent routine preoperative work-up and were assessed by a specialized team, including surgeon, endocrinologist, anesthetist, psychiatrist, and a dietician.
Operative Technique We used a 5-port laparoscopic surgery to access the abdominal cavity. We started with complete devascularization of the greater curvature of the stomach, 4 cm from the pylorus till the left crus of the diaphragm, using the harmonic scalpel (Ethicon Endo-Surgery), sealing the gastric branches of gastroepiploic vessels and short gastric vessels. We then performed sleeve gastrectomy (SG), with a 36 Fr orogastric tube as stent with sequential shoots of Echelon Flex 60 Endopath stapler (Ethicon Endo-Surgery) with initial 2 green firings, followed by all gold firings. After ensuring hemostasis, a stay suture was placed at the distal end of SG for countertraction and better visualization of the first part of the duodenum (Fig. 2A). We then performed a dissection of the duodenum, 2 cm distal to the pylorus, using Goldfinger (Ethicon Endo-Surgery) (Fig. 2B); a tape is then placed for traction subsequent to dissection for firing of the stapler. We transected the first part of the duodenum 2 cm from the pylorus, with Echelon Flex 45 Endopath white stapler (Ethicon Endo-Surgery), taking care not to injure the common bile duct (CBD), pancreas, and major vessels in the area (Fig. 2C). The distal duodenal stump was not oversewed. We measured 200 cm of the jejunal loop from the ligament of Treitz. We put 1 stay suture between the jejunal limb and pylorus and made 1.5 cm vertical and oblique enterotomy in the jejunum and the first part of the duodenum, respectively. We performed an oblique enterotomy in the duodenum as we feared kinking of the loop in vertical enterotomy and transection of the pyloric sphincter in transverse enterotomy. We then performed isoperistaltic, totally hand-sewn anastomosis with 3/0 vicryl (Fig. 2D). Air leak teat was performed to check the anastomosis, with air insufflated through the orogastric tube. After the
Volume 23, Number 6, December 2013
www.surgical-laparoscopy.com |
481
Huang et al
Surg Laparosc Endosc Percutan Tech
Volume 23, Number 6, December 2013
Postoperative Management and Follow-up
FIGURE 1. The proposed technique of loop duodenojejunal bypass with sleeve gastrectomy.
All patients were extubated and transferred to the surgical ward after surgery. Postoperative pulmonary care included deep-breathing exercises and early mobilization. Postoperative pain was controlled with an opioid analgesic. A clear-liquid diet was started once patients were fully conscious. The patients were discharged when they were able to tolerate oral fluid, passed flatus, and had no tachycardia, which was usually by day 3 after the operation. Patients were scheduled for follow-up in the outpatient clinic 1 week after discharge. They advanced to soft foods by the third week and solid foods after 1 month. The requirements for diabetes medication were based on the close monitoring of the fasting plasma glucose (FPG). Subsequent follow-ups were carried out after 1, 3, 6, 9, and 12 months. Nutritional status was reviewed by the dietician at each follow-up, and weight, blood pressure, FBG, HbA1c, and C-peptide levels were documented.
Outcome Measures anastomosis, we sewed the antitorsion sutures in the antrum and upper jejunum, 4 cm proximal to the duodenojejunostomy. We then repaired the Peterson defect with a continuous suture. We put 1 Jackson-Pratt drain behind the duodenojejunal anastomosis reaching the sleeve to finish the procedure.
The primary outcome measure was remission of T2DM, on the basis of the criteria established by the American Diabetes Association.7 Remission is said to occur if FPG and HbA1c levels are 1%, the patient’s condition was considered improved. Surgery was considered to have failed if glycemic indices showed no significant improvement or worsened or if additional diabetes medication was required. Secondary outcome measures included changes in weight and biochemical markers. We also analyzed side effects and complications of surgery.
Statistical Analysis Patient data were collected prospectively and verified retrospectively, and then entered into the BMI Centre Clinical Database, a customized computer database (Access, Microsoft Inc.). Descriptive results for continuous variables were presented as means and SDs. The categorical data were given as counts and percentages. Follow-up comparisons were analyzed using the paired t test. When 20% of the cells had expected values of
Novel Metabolic Surgery for Type II Diabetes Mellitus: Loop Duodenojejunal Bypass With Sleeve Gastrectomy Chih-Kun Huang, MD,*w Rajat Goel, MD,* Chi-Ming Tai, MD,* Yung-Chieh Yen, PhD,z Vijayraj D. Gohil, MD,* and Xiao-Yan Chen, MDw
Abstract: A total of 22 (14F/8M) patients with a mean age of 50.3 years (range, 33 to 64 y) and a mean body mass index of 28.4 kg/m2 (range, 21.8 to 38.3 kg/m2) underwent loop duodenojejunal bypass with sleeve gastrectomy from October 2011 to March 2012. The mean duration of onset of type 2 diabetes mellitus was 8 years (range, 1 to 20 y). All patients were on oral hypoglycemic agents; 3 (14%) patients were also using insulin. The mean preoperative glycosylated hemoglobin (HbA1c), fasting plasma sugar, and C-peptide levels dropped from 8.6% (range, 7% to 13.2%), 147 mg/dL (range, 108 to 241 mg/dL), and 2.4 ng/mL (range, 0.7 to 4.1 ng/mL) to 6.2% (range, 5.1% to 9.1%), 110 mg/dL (range, 72 to 234 mg/dL), and 1.3 ng/mL (range, 0.6 to 2.8 ng/mL) at 6 months, respectively. At 6 months, 11 (50%) patients showed type 2 diabetes mellitus remission (HbA1c < 6.0%), and 20 (91%) patients achieved HbA1c < 7.0% without medicine. There were no intraoperative or early postoperative complications. Loop duodenojejunal bypass with sleeve gastrectomy is safe, feasible, and shows good efficacy in terms of glycemic control in this preliminary report with short follow-up. Key Words: loop duodenojejunal bypass, obesity, sleeve gastrectomy, type 2 diabetes mellitus
(Surg Laparosc Endosc Percutan Tech 2013;23:481–485)
T
ype 2 diabetes mellitus (T2DM) is a chronic progressive disease and is estimated to affect >300 million people worldwide by the year 2025.1 Surgery has been postulated to achieve remission of T2DM in morbidly obese patients.2–6 In one systemic review and meta-analysis, Roux-en-Y gastric bypass (RYGB), biliopancreatic diversion (BPD), and gastric banding were reported to induce T2DM remission in 83.7%, 98.9%, and 47.9% of patients, respectively.5 Although RYGB and BPD have shown satisfactory remission rates, these procedures are associated with their own set of longterm complications, such as marginal ulcers, internal hernias, dumping syndrome, malnutrition, and, in some cases, mortality. The aim of metabolic surgery is to produce remission of T2DM with more physiological procedures and minimal morbidity and mortality. We have tried to develop loop duodenojejunal bypass with sleeve gastrectomy (LDJB-SG), a new bariatric procedure, as a proposed technique for treatment of T2DM patients to achieve this aim (Fig. 1).
Received for publication December 26, 2012; accepted March 24, 2013. From the *Bariatric & Metabolic International (BMI) Surgery Centre; zDepartment of Psychiatry, E-Da Hospital, Kaohsiung, Taiwan; and wFirst Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. The authors declare no conflicts of interest. Reprints: Chih-Kun Huang, MD, Department of General Surgery, Bariatric & Metabolic International Surgery Centre, E-Da Hospital, 1, E-Da Rd, Jian-Shu Tsuen, Yan-Chau Shiang, Kaohsiung 824, Taiwan (e-mail: [email protected]). Copyright r 2013 by Lippincott Williams & Wilkins
Surg Laparosc Endosc Percutan Tech
MATERIALS AND METHODS The study was conducted with the approval of the ethics committee and institutional review board of the E-Da Hospital and also registered with Current Controlled Trials (ISRCTN63241920). All patients gave written informed consent after understanding the risks and benefits associated with the procedure. Inclusion criteria were: age between 18 and 65 years and poorly controlled T2DM for at least 6 months with a glycosylated hemoglobin (HbA1c) level of Z7.0%. Exclusion criteria were: patients younger than 18 or older than 65 years, those planning pregnancy in next 2 years, type 1 diabetes mellitus, latent autoimmune diabetes in adults, malignancy, debilitating disease, unresolved psychiatric illness, substance abuse, and American Society of Anesthesiologists classification >III. All patients underwent routine preoperative work-up and were assessed by a specialized team, including surgeon, endocrinologist, anesthetist, psychiatrist, and a dietician.
Operative Technique We used a 5-port laparoscopic surgery to access the abdominal cavity. We started with complete devascularization of the greater curvature of the stomach, 4 cm from the pylorus till the left crus of the diaphragm, using the harmonic scalpel (Ethicon Endo-Surgery), sealing the gastric branches of gastroepiploic vessels and short gastric vessels. We then performed sleeve gastrectomy (SG), with a 36 Fr orogastric tube as stent with sequential shoots of Echelon Flex 60 Endopath stapler (Ethicon Endo-Surgery) with initial 2 green firings, followed by all gold firings. After ensuring hemostasis, a stay suture was placed at the distal end of SG for countertraction and better visualization of the first part of the duodenum (Fig. 2A). We then performed a dissection of the duodenum, 2 cm distal to the pylorus, using Goldfinger (Ethicon Endo-Surgery) (Fig. 2B); a tape is then placed for traction subsequent to dissection for firing of the stapler. We transected the first part of the duodenum 2 cm from the pylorus, with Echelon Flex 45 Endopath white stapler (Ethicon Endo-Surgery), taking care not to injure the common bile duct (CBD), pancreas, and major vessels in the area (Fig. 2C). The distal duodenal stump was not oversewed. We measured 200 cm of the jejunal loop from the ligament of Treitz. We put 1 stay suture between the jejunal limb and pylorus and made 1.5 cm vertical and oblique enterotomy in the jejunum and the first part of the duodenum, respectively. We performed an oblique enterotomy in the duodenum as we feared kinking of the loop in vertical enterotomy and transection of the pyloric sphincter in transverse enterotomy. We then performed isoperistaltic, totally hand-sewn anastomosis with 3/0 vicryl (Fig. 2D). Air leak teat was performed to check the anastomosis, with air insufflated through the orogastric tube. After the
Volume 23, Number 6, December 2013
www.surgical-laparoscopy.com |
481
Huang et al
Surg Laparosc Endosc Percutan Tech
Volume 23, Number 6, December 2013
Postoperative Management and Follow-up
FIGURE 1. The proposed technique of loop duodenojejunal bypass with sleeve gastrectomy.
All patients were extubated and transferred to the surgical ward after surgery. Postoperative pulmonary care included deep-breathing exercises and early mobilization. Postoperative pain was controlled with an opioid analgesic. A clear-liquid diet was started once patients were fully conscious. The patients were discharged when they were able to tolerate oral fluid, passed flatus, and had no tachycardia, which was usually by day 3 after the operation. Patients were scheduled for follow-up in the outpatient clinic 1 week after discharge. They advanced to soft foods by the third week and solid foods after 1 month. The requirements for diabetes medication were based on the close monitoring of the fasting plasma glucose (FPG). Subsequent follow-ups were carried out after 1, 3, 6, 9, and 12 months. Nutritional status was reviewed by the dietician at each follow-up, and weight, blood pressure, FBG, HbA1c, and C-peptide levels were documented.
Outcome Measures anastomosis, we sewed the antitorsion sutures in the antrum and upper jejunum, 4 cm proximal to the duodenojejunostomy. We then repaired the Peterson defect with a continuous suture. We put 1 Jackson-Pratt drain behind the duodenojejunal anastomosis reaching the sleeve to finish the procedure.
The primary outcome measure was remission of T2DM, on the basis of the criteria established by the American Diabetes Association.7 Remission is said to occur if FPG and HbA1c levels are 1%, the patient’s condition was considered improved. Surgery was considered to have failed if glycemic indices showed no significant improvement or worsened or if additional diabetes medication was required. Secondary outcome measures included changes in weight and biochemical markers. We also analyzed side effects and complications of surgery.
Statistical Analysis Patient data were collected prospectively and verified retrospectively, and then entered into the BMI Centre Clinical Database, a customized computer database (Access, Microsoft Inc.). Descriptive results for continuous variables were presented as means and SDs. The categorical data were given as counts and percentages. Follow-up comparisons were analyzed using the paired t test. When 20% of the cells had expected values of
