Trial Outcomes & Findings for Safety and Efficacy of Long Limb Roux-en Y Reconstruction (NCT NCT01373346)

NCT ID: NCT01373346

Last Updated: 2012-09-03

Results Overview

For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)). HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
• Results posted on: 2012-09-03

Participant Flow

If Patients were eligible for the study, each patient was informed of the investigational nature of the trial and received detailed information regarding the study protocol. All patients provided written informed consent before their enrollment. The enrollment continued from February 2010 through May 2011 in Gangnam Severance Hospital.

Participant milestones

Measure	Long Limb Roux-en Y Reconstruction Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Long Limb Roux-en Y Reconstruction Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
Overall Study Death	1

Baseline Characteristics

Safety and Efficacy of Long Limb Roux-en Y Reconstruction

Baseline characteristics by cohort

Measure	Long Limb Roux-en Y Reconstruction n=15 Participants Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	62.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Korea, Republic of	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Until end of study (on average 14.8 months)

Population: All of enrolled patient were included. (N=15)

For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.

*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.

For the evaluation of long-term safety, the patients were evaluated every month after discharge.

Outcome measures

Measure

Long Limb Roux-en Y Reconstruction n=15 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.

Morbidity

4 participants

PRIMARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).

HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
HbA1c Before operation	7.7 percentage of glycated hemoglobin Standard Deviation 1.4
HbA1c 6 months after operation	6.3 percentage of glycated hemoglobin Standard Deviation 0.8
HbA1c Until end of study (on average 14.8 months)	6.3 percentage of glycated hemoglobin Standard Deviation 0.8

PRIMARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.

For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Hemoglobin Before operation	13.0 g/dl Standard Deviation 1.7
Hemoglobin 6 months after operation	12.5 g/dl Standard Deviation 1.6
Hemoglobin Until end of study (on average 14.8 months)	12.5 g/dl Standard Deviation 1.8

PRIMARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.

For the evaluation of long-term safety, albumin was measured to determine malnutrition.

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Albumin 6 months after operation	4.3 g/dl Standard Deviation 0.6
Albumin Before operation	4.4 g/dl Standard Deviation 0.4
Albumin Until end of study (on average 14.8 months)	3.9 g/dl Standard Deviation 0.7

PRIMARY outcome

Timeframe: Until end of study (on average 14.8 months)

Population: All of enrolled patient were included.(N=15)

Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.

Outcome measures

Measure

Long Limb Roux-en Y Reconstruction n=15 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.

Operation Related Mortality

0 participants

SECONDARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

Matsuda Index(Insulin Sensitivity Index) was measured.

The Matsuda index was obtained using the following formula:

Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Matsuda Index 6 months after operation	15.4 units on a scale Standard Deviation 10.9
Matsuda Index Before operation	7.2 units on a scale Standard Deviation 5.0
Matsuda Index Until end of study (on average 14.8 months)	17.1 units on a scale Standard Deviation 10.5

SECONDARY outcome

Timeframe: Before operation , 6 months after operation , Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

The quantitative insulin sensitivity check index (QUICKI) was measured.

The QUICKI was obtained using the following formula:

1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
QUICKI Pre Operation	0.4 units on a scale Standard Deviation 0.1
QUICKI 6 months after operation	0.4 units on a scale Standard Deviation 0.0
QUICKI Until end of study (on average 14.8 months)	0.4 units on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.

HOMA-IR was obtained using the following formula:

Glucose(mg/dl) x Insulin/405

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
HOMA-IR Before operation	2.2 units on a scale Standard Deviation 2.4
HOMA-IR 6 months after operation	1.0 units on a scale Standard Deviation 0.8
HOMA-IR Until End of study(on average 14.8 months)	1.0 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.

HOMA-B was obtained using the following formula:

225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
HOMA-B Before operation	7.7 percentage of beta cell function Standard Deviation 7.1
HOMA-B 6 months after operation	13.4 percentage of beta cell function Standard Deviation 8.1
HOMA-B Until end of study (on average 14.8 months)	16.0 percentage of beta cell function Standard Deviation 11.1

SECONDARY outcome

Timeframe: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

BMI(Body Mass index , kg/㎡) was measured.

BMI was obtained using the following formula:

Weight (kg) / (Height (m) x Height (m))

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=14 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Body Mass Index Before operation	25.2 kg/㎡ Standard Deviation 3.4
Body Mass Index 6 months after operation	21.7 kg/㎡ Standard Deviation 3.1
Body Mass Index Until end of study (on average 14.8 months)	21.2 kg/㎡ Standard Deviation 2.8

SECONDARY outcome

Timeframe: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of insulin sensitivity after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group.

The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:

Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Matsuda Index : Good Response Group Before operation	5.7 units on a scale Standard Deviation 3.0
Matsuda Index : Good Response Group 6 months after operation	14.6 units on a scale Standard Deviation 6.1
Matsuda Index : Good Response Group Until end of study (on average 14.8 months)	12.7 units on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of QUICKI after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.

The QUICKI is obtained using the following formula:

1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
QUICKI : Good Response Group Before Operation	0.4 units on a scale Standard Deviation 0.1
QUICKI : Good Response Group 6 months after operation	0.4 units on a scale Standard Deviation 0.0
QUICKI : Good Response Group Until end of study (on average 14.8 months)	0.5 units on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of HOMA-IR after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group.

HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.

HOMA-IR was obtained using the following formula:

Glucose(mg/dl) x Insulin/405

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
HOMA-IR : Good Response Group Before operation	1.9 units on a scale Standard Deviation 1.9
HOMA-IR : Good Response Group 6 months after operation	0.9 units on a scale Standard Deviation 0.7
HOMA-IR : Good Response Group Until end of study (on average 14.8 months)	0.8 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of beta cell function after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.

HOMA-B was obtained using the following formula:

225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
HOMA-B : Good Response Group Before operation	8.7 percentage of beta cell function Standard Deviation 6.9
HOMA-B : Good Response Group 6 months after operation	13.4 percentage of beta cell function Standard Deviation 8.9
HOMA-B : Good Response Group Until end of study (on average 14.8 months)	17.8 percentage of beta cell function Standard Deviation 12.3

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of weight after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group.

BMI(Body Mass index , kg/㎡) was measured.

BMI was obtained using the following formula:

Weight (kg) / (Height (m) x Height (m))

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Body Mass Index : Good Response Group Before operation	25.7 kg/㎡ Standard Deviation 3.5
Body Mass Index : Good Response Group 6 months after operation	22.0 kg/㎡ Standard Deviation 3.3
Body Mass Index : Good Response Group Until end of study (on average 14.8 months)	21.5 kg/㎡ Standard Deviation 2.6

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of HbA1c after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group.

HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)

The HbA1c was calculated as a ratio to total hemoglobin.

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
HbA1c : Good Response Group Before operation	7.2 percentage of glycated hemoglobin Standard Deviation 1.1
HbA1c : Good Response Group 6 months after operation	6.0 percentage of glycated hemoglobin Standard Deviation 0.5
HbA1c : Good Response Group Until end of study (on average 14.8 months)	6.0 percentage of glycated hemoglobin Standard Deviation 0.6

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group.

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Hemoglobin : Good Response Group Before operation	13.0 g/dl Standard Deviation 1.7
Hemoglobin : Good Response Group 6 months after operation	12.5 g/dl Standard Deviation 1.6
Hemoglobin : Good Response Group Until end of study (on average 14.8 months)	12.5 g/dl Standard Deviation 1.8

SECONDARY outcome

Timeframe: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety.

Outcome measures

Measure	Long Limb Roux-en Y Reconstruction n=11 Participants Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
Albumin : Good Response Group Before operation	4.4 g/dl Standard Deviation 0.4
Albumin : Good Response Group 6 months after operation	4.2 g/dl Standard Deviation 0.6
Albumin : Good Response Group Until end of study (on average 14.8 months	3.9 g/dl Standard Deviation 0.7

Adverse Events

Long-limb Roux-en Y Reconstruction

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Long-limb Roux-en Y Reconstruction n=15 participants at risk Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
Cardiac disorders myocardiac infart	6.7% 1/15 • Number of events 1 • Until end of study (on average 14.8 months) Daily check up during hospitalization after operation. check up every month after discharge.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) dead	6.7% 1/15 • Number of events 1 • Until end of study (on average 14.8 months) Daily check up during hospitalization after operation. check up every month after discharge.

Other adverse events

Measure	Long-limb Roux-en Y Reconstruction n=15 participants at risk Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
Surgical and medical procedures Anastomosis, non-functional (morphologic abnormality)	6.7% 1/15 • Number of events 1 • Until end of study (on average 14.8 months) Daily check up during hospitalization after operation. check up every month after discharge.
Surgical and medical procedures Stricture of anastomosis of intestine	6.7% 1/15 • Number of events 1 • Until end of study (on average 14.8 months) Daily check up during hospitalization after operation. check up every month after discharge.
Skin and subcutaneous tissue disorders Open wound of abdominal wall with complication	6.7% 1/15 • Number of events 1 • Until end of study (on average 14.8 months) Daily check up during hospitalization after operation. check up every month after discharge.

Additional Information

Seung Ho Choi, M.D., Ph.D.

Gangnam severance hospital

Phone: 82-2-2019-3374

Email: choish@yuhs.ac

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place