Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy - Full Text View

Sponsored by:	The Catholic University of Korea
Information provided by:	The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT00622804

Purpose

The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.

We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).

Condition	Intervention	Phase
Stomach Cancer Gastrectomy	Procedure: Billroth-II (B-II) Procedure: Roux en Y gastrojejunostomy (RY-GJ) Procedure: uncut Roux en Y gastrojejunostomy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:

Bile reflux by Dual scintigraphy [ Time Frame: six month and one year after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gastric emptying time by Dual scintigraphy [ Time Frame: six month and one year after operation ] [ Designated as safety issue: No ]
Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings [ Time Frame: six month and one year after operation ] [ Designated as safety issue: No ]
Quality of life by EORTC QLQ30, STO22 [ Time Frame: one year after operation ] [ Designated as safety issue: No ]
Morbidity and Mortality [ Time Frame: In hosipital ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	July 2007
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Billroth-II (B-II)reconstruction	Procedure: Billroth-II (B-II) After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.
2 Roux en Y gastrojejunostomy (RY-GJ)	Procedure: Roux en Y gastrojejunostomy (RY-GJ) After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.
3 uncut Roux en Y gastrojejunostomy (uncut RY-GJ)	Procedure: uncut Roux en Y gastrojejunostomy After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.

Detailed Description:

Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on. From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
1. have cancer located in middle or distal portions
2. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
3. have The American Society of Anaesthesiologists (ASA) score of three and less

Exclusion Criteria:

Patients following criteria:
1. have simultaneously other cancer
2. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
3. have systemic inflammatory disease
4. have upper gastrointestinal surgery
5. have the gastric cancer with obstruction
6. get pregnancy
7. are treating diabetics with Insulin
8. are participating or participated within 1 month in other clinical trials
9. have BMI less than 25
10. are expected to perform laparoscopy assisted gastrectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622804

Locations

Korea, Republic of
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 150-713
Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-710
Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea
In Cheon, Korea, Republic of, 403-720
Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea
Suwon, Korea, Republic of, 442-723
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
Bucheon, Korea, Republic of, 420-717

Sponsors and Collaborators

The Catholic University of Korea

Investigators

Principal Investigator:

Wook Kim, MD, PhD

Department of Surgery, Holy Family Hospital, The Catholic University of Korea

More Information

Additional Information:

CMC Clinical Research Coordinating Center, The Catholic University of Korea This link exits the ClinicalTrials.gov site

Publications:

Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. Epub 2004 Sep 6.

Responsible Party:	Department of Surgery, Holy Family Hospital, College of Medicine ( Wook Kim )
Study ID Numbers:	HCHC06OT049
Study First Received:	February 14, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00622804 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:

Stomach cancer
Gastrectomy
Postgastrectomy syndrome

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Bile Reflux

Stomach Neoplasms
Biliary Tract Diseases
Gastrointestinal Neoplasms
Neurologic Manifestations
Stomach Cancer
Gastroparesis

Additional relevant MeSH terms:

Duodenogastric Reflux
Digestive System Neoplasms
Gastrointestinal Diseases
Paralysis
Signs and Symptoms
Neoplasms
Digestive System Diseases
Stomach Diseases

Neoplasms by Site
Bile Reflux
Stomach Neoplasms
Biliary Tract Diseases
Neurologic Manifestations
Gastrointestinal Neoplasms
Gastroparesis

ClinicalTrials.gov processed this record on September 03, 2009