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Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy

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ClinicalTrials.gov Identifier: NCT01142271
Recruitment Status : Unknown
Verified November 2011 by Sang-Uk Han, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : June 11, 2010
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Sang-Uk Han, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 8, 2010
First Posted Date  ICMJE June 11, 2010
Last Update Posted Date November 7, 2011
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Reflux of bile content [ Time Frame: 6 months after surgery ]
We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01142271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
  • Quality of Life [ Time Frame: 6 months after surgery ]
    We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).
  • Morbidity [ Time Frame: 2 month after surgery ]
    We investigate the occurrence of complication during recovery after surgery.
  • Anastomotic time [ Time Frame: Day 1 ]
    We estimate anastomosis time
  • Nutritional state [ Time Frame: 6 month after surgery ]
    We estimate Albumin, transferrin, lymphocyte, body weight
  • Mortality [ Time Frame: 2 month after operation ]
    We investigate the occurrence of operation-related death during recovery after surgery.
  • Operation time [ Time Frame: Day 1 ]
    We estimate total operation time.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy
Official Title  ICMJE Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study
Brief Summary The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
Detailed Description

Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.

Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastrectomy
Intervention  ICMJE
  • Procedure: Billroth-I
    Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
    Other Name: Gastroduodenostomy
  • Procedure: Roux en Y
    Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.
    Other Name: Gastrojejunostomy and jejunojejunostomy
Study Arms  ICMJE
  • Experimental: Billroth-I
    Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.
    Intervention: Procedure: Billroth-I
  • Experimental: Roux en Y
    Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.
    Intervention: Procedure: Roux en Y
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2010)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with adenocarcinoma at the endoscopic biopsy
  • Patients who are possible to be performed curative resection in imaging study
  • Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
  • Patients with informed consent
  • Patients with three or less American Society Anesthesiology Score 3

Exclusion Criteria:

  • Patients who are or become pregnant
  • Patients with uncontrolled disease
  • Patient s with synchronous other malignancy
  • Patients participated in other clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01142271
Other Study ID Numbers  ICMJE AJIRB-MED-DEO-09-297
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang-Uk Han, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang-Uk Han, M.D., Ph D. Department of Surgery, Ajou University School of Medicine
Study Director: Hoon Hur, M.D. Department of Surgery, Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP