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OpenTrials
Completed

NCT Number: NCT02892643

Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soonchunhyang University Bucheon Hospital, Bucheon-si, South Korea

Loading trial locations.

About this study

Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.

Patients Registration It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Bundang Hospital Medical Research Collaborating Center.

Each group 69 patients, total 138 subjects will be enrolled. Randomization The registration randomization should be done with 1:1 ratio for each researcher.

Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.

Procedure Operations are performed according to the allocated group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are included in the trial if they meet all of the following criteria:

Histologically proven adenocarcinoma through endoscopic biopsy Aged 20-80 years old Written signed informed consent No other malignancies Proximal gastric cancer met by following conditions ; Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to mucosa or submucosa (cT1) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis.

Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score

Exclusion criteria

  • Patients are excluded if they meet any of the following criteria:

History of anemia Patients who need total gastrectomy History of pre-operative chemotherapy or radiation therapy for gastric cancer Patients who need combined resection (except cholecystectomy) Presence of other malignancies Prior treatment against systemic inflammatory disease Previous gastric surgery Vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)

Treatment and study plan

Laparoscopic proximal gastrectomy

Procedure

Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Laparoscopic total gastrectomy

Procedure

Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Primary outcomes

  1. Change of Hemoglobin

    Time frame: up to 2 years postoperatively

    from blood sample

  2. Vitamin B12 cumulative supplement quantity

    Time frame: up to 2 years postoperatively

    from blood sample

Secondary outcomes

  1. Operative morbidity

    Time frame: 30 days for early morbidity

    Complications occuring after operation

  2. Operative mortality

    Time frame: mortality for 90 days

    Mortality after operation

  3. QOL measurement

    Time frame: 6 month, 1 year, 2 year, postoperatively

    EORTC C30/STO22

  4. Reflux esophagitis

    Time frame: check at every 12 months up to 2 years postoperatively

    assessed by Visick score and endoscopic grading according to LA classification

  5. Relapse-free survival

    Time frame: 2 years postoperatively

    Relapse-free survival

  6. Overall survival

    Time frame: 2 years postoperatively

    Overall survival

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Multicenter Prospective Randomized Controlled Trial of Comparing Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy for Upper Third Early Gastric Cancer (KLASS-05)

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Sep 8, 2016
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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