Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00622804
Other study ID # HCHC06OT049
Secondary ID
Status Withdrawn
Phase Phase 3
First received February 14, 2008
Last updated July 31, 2009
Start date July 2007

Study information

Verified date July 2009
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 90
Est. completion date
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

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


Intervention

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.
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.
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.

Locations

Country Name City State
Korea, Republic of Department of Surgery, Holy Family Hospital, The Catholic University of Korea Bucheon
Korea, Republic of Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea In Cheon
Korea, Republic of Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea Seoul
Korea, Republic of Department of Surgery, St Mary's Hospital, The Catholic University of Korea Seoul
Korea, Republic of Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea Suwon

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Bile reflux by Dual scintigraphy six month and one year after operation No
Secondary Gastric emptying time by Dual scintigraphy six month and one year after operation No
Secondary Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings six month and one year after operation No
Secondary Quality of life by EORTC QLQ30, STO22 one year after operation No
Secondary Morbidity and Mortality In hosipital Yes
See also
  Status Clinical Trial Phase
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT02604979 - The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study N/A
Active, not recruiting NCT00394433 - Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer Phase 2
Completed NCT00201747 - Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer Phase 2
Completed NCT00215514 - Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma Phase 0
Recruiting NCT04486651 - HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer Phase 3
Recruiting NCT05415475 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors Phase 1
Recruiting NCT04526470 - Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer Phase 1/Phase 2
Completed NCT01257711 - A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer N/A
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Withdrawn NCT03704077 - An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Phase 2
Recruiting NCT05489250 - The PLATON Network
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Completed NCT02547064 - Effect of Modified Stylet Angulation on the Intubation With GlideScope® N/A
Withdrawn NCT00800969 - Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach Phase 2
Completed NCT00296322 - Trial of Adjuvant Chemotherapy for Gastric Cancer Phase 3
Recruiting NCT04215861 - Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy
Recruiting NCT06199895 - Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer Phase 2
Recruiting NCT01038154 - Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer Phase 4