Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy

This study has been withdrawn prior to enrollment.
(It was very difficult to enroll patients in this study.)
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00622804
First received: February 14, 2008
Last updated: July 31, 2009
Last verified: July 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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.
Other Name: B-II
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.
Other Name: RY-GJ
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.
Other Name: uncut RY-GJ

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
Bucheon, Korea, Republic of, 420-717
Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea
In Cheon, Korea, Republic of, 403-720
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, St. Vincent's Hopital, The Catholic University of Korea
Suwon, Korea, Republic of, 442-723
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:
Publications:
Responsible Party: Wook Kim, Department of Surgery, Holy Family Hospital, College of Medicine
ClinicalTrials.gov Identifier: NCT00622804     History of Changes
Other Study ID Numbers: HCHC06OT049
Study First Received: February 14, 2008
Last Updated: July 31, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
Stomach cancer
Gastrectomy
Postgastrectomy syndrome

Additional relevant MeSH terms:
Stomach Neoplasms
Gastroparesis
Bile Reflux
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Duodenogastric Reflux

ClinicalTrials.gov processed this record on September 18, 2014