MEGA Trial - Minimally invasivE versus open Gastrectomy. A multicenter randomized controlled trial.
Organizational Data
- DRKS-ID:
- DRKS00025765
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-12-22
- Last update in DRKS:
- 2024-01-16
- Registration type:
- Prospective
Acronym/abbreviation of the study
MEGA
URL of the study
Brief summary in lay language
Patients diagnosed with a gastric cancer tumor require removal of the stomach by surgery. The current standard is to perform this surgery openly through the abdominal cavity. This treatment leads to potentially higher complication rates, especially in elderly and obese patients. These complications, in turn, lead to higher mortality, lower quality of life, longer hospital stay, and thus a higher burden on the healthcare system. In recent years, minimally invasive surgery ("small incision surgery" or "keyhole surgery") has developed rapidly and it is already the standard in some areas and tumors of the stomach to remove. Several studies have shown fewer complications after minimally invasive surgery compared with the open approach, due to smaller wounds, less surgical trauma, less blood loss, shorter hospital stay, and faster recovery. The goal of this study is to prove that minimally invasive surgery reduces severe complications and pain, allows for better range of motion, restores physical and mental abilities more quickly, and allows for a shorter hospital stay compared to open surgery. Through this study, surgeons will be better able to educate patients about the benefits and risks of surgery using high-quality data. Potentially fewer complications will be associated with a shorter hospital stay, which in turn would reduce the burden on the healthcare system.
Brief summary in scientific language
People diagnosed with gastric tumor require surgery to remove the stomach. The previous standard is open gastrectomy. In recent years, minimally invasive surgery ("small incision surgery" or "keyhole surgery") has developed rapidly and is already replacing open surgery as the standard therapy for many general surgical operations. In gastric cancer, too, some studies show that the minimally invasive approach potentially reduces complication rates with equivalent chances of cure. The goal of this study is to show a reduction in severe complications and postoperative pain, better mobilization, faster rehabilitation, and shorter hospital stay after minimally invasive gastrectomy compared with open gastrectomy. For this reason, the Comprehensive Complication Index (CCI), based on the Clavien-Dindo classification, was chosen as the primary endpoint because this well-established index encompasses all possible complications and thus also reflects the patient's assessment better than other indices. Through this study, surgeons will be better able to educate patients about the benefits and risks of surgery using high-quality data, as well as improve the surgical management of gastric cancer through low complication and faster rehabilitation of patients. This would be associated with a shorter hospital stay, which in turn would reduce the burden on the healthcare system.
Health condition or problem studied
- ICD10:
- C16 - Malignant neoplasm of stomach
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Minimally invasive gastrectomy
- Arm 2:
- Open gastrectomy
Endpoints
- Primary outcome:
- Postoperative morbidity measured with the Comprehensive Complication Index (CCI) until postoperative day (POD) 30
- Secondary outcome:
- Short-term clinical endpoints: - Postoperative morbidity measured with the CCI until POD 90 - Major complications (Clavien-Dindo ≥ 3) until POD 90 - Conversion rate - Operation time calculated from incision to skin closure - Blood loss as estimated by the surgeons - Length of stay in the ICU - Length of hospital stay - Pain and postoperative analgesic required (visual analog scale of pain and given medication) - Laboratory parameters (CRP, leucocytes) - Mobilization of the patient as time to achieved first mobilization to the edge of the bed as well as to the first postoperative walk - Quality of the patient's recovery score (QoR-15) - Quality of life (QoL) as "patient reported outcome" (PRO) using established questionnaires (EUROQOL EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-STO22, ADLs) - Adherence to a fast-track gastrectomy SOP - Objective evaluation of anastomoses - First bowl function and mobilization - Wound healing deficits - Vegetative function - Necessity of interventions due to complications Oncologic short-term endpoints: - Number of lymph nodes removed - Number of tumor-positive lymph nodes - Number of R0 resections - Development of tumor markers (Carbohydrate antigen (CA) 125, CA 19-9, CA 72-4, Carcinoembryonic antigen (CEA)) - Tumor histopathology Long-term clinical endpoints (5-year FU): - Changes of body weight - QoL as “patient reported outcome” (PRO) using established questionnaires (EUROQOL EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-STO22, ADLs, BIS) - Incidence of incisional hernias - Incidence of reoperations - Incidence of stenosis of anastomoses requiring interventional treatment - Cosmetic results and scar satisfaction Oncologic long-term endpoints (5-year FU): - Oncological treatment (adjuvant and consecutive therapy) - Disease-free survival; recurrence free survival - Local recurrence - Relapse-free survival - Progression-free survival - Time to progression - Overall survival
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg
Recruitment period and number of participants
- Planned study start date:
- 2023-12-01
- Actual study start date:
- 2023-12-04
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 160
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 84 Years
- Additional Inclusion Criteria:
- - Planned total gastrectomy after first diagnosis of gastric cancer - Ability of patient to understand character and individual consequences of the clinical trial - Written informed consent
Exclusion Criteria
- ECOG performance status > 2 - Planned extended gastrectomy or less than total gastrectomy (e.g. adenocarcinoma of esophagogastric junction (AEG) I and AEG II, distal gastric tumors of intestinal subtype) - Previous gastric surgery or extensive adhesions seriously complicating MIG - Other active oncologic disease or history of cancer limiting prognosis in comparison to the gastric cancer - Emergency setting - Language problems rendering patient unable to fill out patient reported outcome questionnaires - Participation in another intervention-trial with interference of intervention and/or outcome of this trial - Pregnancy Exclusion criteria previously or during staging laparoscopy: - T4 - M1
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum HeidelbergIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Hamburg-Eppendorf (UKE)PD Dr. med. Felix NickelMartinstraße 5220246 HamburgGermany
- Telephone:
- +49 (0) 40 7410-52401
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Hamburg-Eppendorf (UKE)PD Dr. med. Felix NickelMartinstraße 5220246 HamburgGermany
- Telephone:
- +49 (0) 40 7410-52401
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Hamburg-Eppendorf (UKE)PD Dr. med. Felix NickelMartinstraße 5220246 HamburgGermany
- Telephone:
- +49 (0) 40 7410-52401
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung - DLR ProjektträgerHeinrich-Konen-Straße 153170 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-10-15
- Ethics committee number:
- S-816/2021
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-12-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry