Laparoscopic Versus Open Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

— LOGICA  

Official title:

Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02248519
• Other study ID #: NL47444.041.14
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2023

Study information

• Verified date: September 2020
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: December 2023
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven adenocarcinoma of the stomach

• Surgically resectable (cT1-4a, N0-3b, M0) tumor

• Age = 18 years

• European Clinical Oncology Group (ECOG) performance status 0, 1 or 2.

• Written informed consent

Exclusion Criteria:

• Siewert type I esophagogastric junction tumor

• Non-elective surgery

• Previous gastric resection or recurrent gastric cancer

• Pregnancy

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Open Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
• Laparoscopic Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.

Locations

Country	Name	City	State
Netherlands	Zorggroep Twente Almelo	Almelo
Netherlands	Meander Medical Center	Amersfoort
Netherlands	Academic Medical Center	Amsterdam
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Gelre Hospital	Apeldoorn
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Zuyderland Medical Center	Sittard-Geleen
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Johnson & Johnson, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewé KW, Spillenaar Bilgen EJ, Rütter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perioperative blood loss	Measured in milliliters (ml)	Post-operative day 1
Other	Operative time	The time from incision to closure of all wounds in minutes (min)	Post-operative day 1
Other	Conversion rate	The percentage (%) of laparoscopic gastrectomies that had to be converted intra-operatively to an open procedure due to any reason.	Post-operative day 1
Other	Survival	Measured as 5-year disease free survival and 5-year overall survival	Up to 5 years post-operative
Other	VAS-score		Post-operative day 1 and 2
Other	Surgeons ergonomics	Measured with the Subjective Mental Effort Questionnaire (SMEQ)	Post-operative day 1
Other	Time to return to normal nutritional regime		Up to 5 years post-operative
Other	Time to return to daily activity		Up to 5 years post-operative
Primary	Post-operative hospital stay	The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures.	During admission, an expected average of 2 weeks
Secondary	Mortality	Measured as 30-day mortality rate	30 days post-operative
Secondary	Post-operative morbidity	Complications will be classified according to the Clavien-Dindo system and include anastomotic leakage, anastomotic stricture, respiratory complications, cardiac complications, intra-abdominal bleeding , intra-abdominal abscess, sepsis, ileus, wound infection, fistula, urinary tract infection and dumping syndrome	Up to 5 years post-operative
Secondary	Cost-effectiveness	Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation	Up to 5 years post-operative
Secondary	Quality of Life	The validated quality of life questionnaires EORTC QLQ-30, EORTC QLQ-STO22 and EQ-5D-5L, will be filled in pre-operative <5 days and post-operative at 6 weeks, 12, 24, 36, 48 and 60 months after surgery.	Up to 5 years post-operative
Secondary	Readmissions	The number of post-operative readmissions	Up to 5 years post-operative
Secondary	Oncologic outcomes (R0-resection rate and lymph node yield)	R0-resection rate of the distal and proximal margin, defined according to the College of American Pathologists. Lymph node yield: the amount of harvested lymph nodes per patient.	Pathology report 1-2 weeks after surgery