Gastric CancerDRAGNCT04288661
Perianastomotic Drain After Gastrectomy (DRAG)
A study testing No drain placement in people with Gastric Cancer, run by THEODOROU DIMITRIOS at 1 site in Greece.
Trial summary
Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- No drain placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 28 Feb 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Histologically proven EGJ (Siewert II or III) or non-EGJ gastric adenocarcinoma (intestinal, diffuse, or mixed Lauren type)
- Surgical candidates for total gastrectomy plus D2 lymph node dissection
- ECOG performance status 0 or 1
- Signed informed consent from
- Preoperative evaluation of cTanyNanyM0 according to the American Joint Committee on Cancer Staging Manual, 7th edition
Who cannot join
- M1 disease
- Other unplanned organ excision
- Massive ascites or cachexia
- Current participation in any other clinical trial
- Severe cardiovascular, respiratory tract, kidney, liver, or psychiatric disease.
- Poor compliance to the clinical protocol
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer
Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract reconstruction .It has long been established that minimizing surgical intervention correlates with faster patient recovery. The Enhanced Recovery After Surgery (ERAS) guidelines provide globally recognized perioperative recommendations for a variety of surgical procedures, grounded in research, audits, and evidence-based practice. In 2014, Mortensen et al. introduced ERAS guidelines specifically tailored for gastrectomy in gastric cancer. These guidelines include both procedure-specific and general recommendations applicable to the perioperative management of abdominal surgeries.Since the publication of ERAS guidelines, evidence suggests limited and inconsistent global adherence to the protocol for gastrectomy, particularly regarding surgical drain use.Drains remain in use for gastrectomy, particularly in the East, where ongoing studies explore the prognostic value of drain contents post-gastrectomy without reaching consensus. Western adherence to ERAS recommendations on drains is similarly low.This prospective, non-randomized controlled clinical trial aims to assess the impact of one perianastomotic drain when it is placed under specific, predefined criteria. The trial evaluates the immediate and short-term postoperative outcomes in patients who underwent D2 total gastrectomy for gastric cancer which were performed in a high-volume centre and under the care of a highly experienced team
Read the detailed description
The DRAG (DRains After Gastrectomy) Trial is a prospective, non-randomized, controlled clinical trial involving patients diagnosed with gastric neoplasm. All surgeries were performed by a single, highly experienced surgeon in the 1st Propaedeutic Surgery Department at Hippocration General Hospital in Athens, Greece. The patients underwent open total gastrectomy with D2 lymph node dissection, followed by Roux-en-Y gastrointestinal tract reconstruction, in accordance with a predefined, ERAS-compliant perioperative departmental protocol. Our institution's protocol does not routinely incorporate exploratory laparoscopy or peritoneal cytology.
The participants were divided into two groups. The first group followed the department's standard practice, with a drain placed near the esophagojejunal anastomosis (drain group). In contrast, the second did not have a drain placed (non-drain group). The decision to place a drain was based on the following criteria:
- Pulmonary diseases under oxygen therapy
- Chronic oral steroid use (≥5mg/day prednisone equivalent for >1month)
- Intraoperative hemodynamic instability requiring vasopressors
- Intraoperative blood loss exceeding 250 mL
- Vessel injury (celiac axis or its branches)
- Injury to adjacent structures (pancreas, spleen, duodenum)
- Tension of the anastomosis
- Uncertainty regarding duodenal stump integrity due to either staple misfire or tissue quality issues Per our departmental protocol, patients were gradually mobilized starting directly after surgery, when feasible. On the second postoperative day, an oral gastrografin study was conducted for each patient to detect any early anastomotic leaks. Following a normal radiological study, patients were initiated on a liquid diet, which was then advanced to pureed food on the third postoperative day, and a soft diet on the fourth day. For patients in the drain group, the drain was removed on the fifth postoperative day, provided that the drainage volume was less than 50 mL over the preceding 48 hours, in line with departmental protocol The primary outcomes measured in this study were: a) pain levels, assessed using the Visual Analog Scale (VAS) during the first 5 postoperative days, b) postoperative nausea and vomiting (PONV) within the first 5 days, c) initiation of feeding, d) postoperative bowel mobilization, e) patient mobilization, f) length of hospital stay (LOS) Secondary outcomes included: a) mortality, b) surgically related readmissions and c) reoperations This study was conducted in accordance with the principles outlined in the Helsinki Declaration of Human Rights and with the Guidelines of Good Clinical Practice . The final study protocol and the informed consent form for participant inclusion received approval from the Institutional Review Board (IRB). The IRB also conducted regular assessments, as required, to ensure the ongoing compliance with lawful medical practice throughout the trial.
The statistical analysis was performed using the R software (R foundation for Statistical Computing) version 4.3.0 for Windows. Descriptive characteristics for the quantitative data were expressed as median and Quartile 1 (Q1) to Quartile 3 (Q3) range and for completeness reasons the mean ± standard deviation (SD), for the qualitative data was reported the frequency of occurrence and the relevant percentage. Comparisons were preformed between patients with drainage and those without drainage; for the qualitative parameters statistical tests were performed via the chi-square test (and if required a Fisher exact test) and for the arithmetic data (as normality was not possible to be ensured using the Shapiro Wilk test), were applied not parametric tests, specifically the Mann Whitney U test. The significance level (p-value) was set to 0.05, thus statistically significant difference between compared groups was for p<0.05 and all tests were two sided.
- Conditions
- Gastric Cancer
- Being tested
- No drain placement
- Keywords
- prophylactic drain, total gastrectomy, gastric cancer, esophagogastric anastomosis leak, drain criteria
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drain placementProcedure or surgery
The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above
| Study group | Role | What they receive |
|---|---|---|
| Drain | No intervention | The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice |
| No drain | Experimental | The patients of this arm do not undergo perianastomotic drain placement. Receives: Procedure: No drain placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)
Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups:
High pain: VAS score greater than 5
Not high pain: VAS score 5 or less
This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain.
Measured: Hospital stay, an average of 5 days
Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days
Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results
Measured: Hospital stay, an average of 5 days
Number of Participants With Delay of Feeding Initiation
immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol
Measured: Hospital stay, an average of 5 days
Number of Participants With Delay of Postoperative Mobilization
immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol.
Measured: Hospital stay, an average of 5 days
Length of Hospital Stay
immediate effect of drain placement
Measured: Hospital stay, an average of 5 days
Day of Postoperative Bowel Mobilization
immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement
Measured: Hospital stay approx 5 days
Secondary outcomes (3)
Mortality
short term effect of drain placement
Measured: 30 days
Surgically Related Readmissions
short term effect of drain placement
Measured: 30 days
Reoperations
short term effect of drain placement
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start28 Feb 2020
- Primary completion28 Feb 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- THEODOROU DIMITRIOS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, THEODOROU DIMITRIOS, University of Athens
- Investigators
- Dimitrios Theodorou, Professor, Study chair, University of AthensMaria-Malvina Eleftheriou, MD, Principal investigator, Hippocration General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288661
- Sponsor's protocol ID
- 1678 / 31-01-2020
- Acronym
- DRAG
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2020
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT04288661
- Acronym / sponsor ID
- DRAG / 1678 / 31-01-2020
- Conditions
- Gastric Cancer
- Keywords
- prophylactic drain, total gastrectomy, gastric cancer, esophagogastric anastomosis leak, drain criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- THEODOROU DIMITRIOSUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract reconstruction .It has long been established that minimizing surgical intervention correlates with faster patient recovery. The Enhanced Recovery After Surgery (ERAS) guidelines provide globally recognized perioperative recommendations for a variety of surgical procedures, grounded in research, audits, and evidence-based practice. In 2014, Mortensen et al. introduced ERAS guidelines specifically tailored for gastrectomy in gastric cancer. These guidelines include both procedure-specific and general recommendations applicable to the perioperative management of abdominal surgeries.Since the publication of ERAS guidelines, evidence suggests limited and inconsistent global adherence to the protocol for gastrectomy, particularly regarding surgical drain use.Drains remain in use for gastrectomy, particularly in the East, where ongoing studies explore the prognostic value of drain contents post-gastrectomy without reaching consensus. Western adherence to ERAS recommendations on drains is similarly low.This prospective, non-randomized controlled clinical trial aims to assess the impact of one perianastomotic drain when it is placed under specific, predefined criteria. The trial evaluates the immediate and short-term postoperative outcomes in patients who underwent D2 total gastrectomy for gastric cancer which were performed in a high-volume centre and under the care of a highly experienced team
Detailed description
The DRAG (DRains After Gastrectomy) Trial is a prospective, non-randomized, controlled clinical trial involving patients diagnosed with gastric neoplasm. All surgeries were performed by a single, highly experienced surgeon in the 1st Propaedeutic Surgery Department at Hippocration General Hospital in Athens, Greece. The patients underwent open total gastrectomy with D2 lymph node dissection, followed by Roux-en-Y gastrointestinal tract reconstruction, in accordance with a predefined, ERAS-compliant perioperative departmental protocol. Our institution's protocol does not routinely incorporate exploratory laparoscopy or peritoneal cytology.
The participants were divided into two groups. The first group followed the department's standard practice, with a drain placed near the esophagojejunal anastomosis (drain group). In contrast, the second did not have a drain placed (non-drain group). The decision to place a drain was based on the following criteria:
- Pulmonary diseases under oxygen therapy
- Chronic oral steroid use (≥5mg/day prednisone equivalent for >1month)
- Intraoperative hemodynamic instability requiring vasopressors
- Intraoperative blood loss exceeding 250 mL
- Vessel injury (celiac axis or its branches)
- Injury to adjacent structures (pancreas, spleen, duodenum)
- Tension of the anastomosis
- Uncertainty regarding duodenal stump integrity due to either staple misfire or tissue quality issues Per our departmental protocol, patients were gradually mobilized starting directly after surgery, when feasible. On the second postoperative day, an oral gastrografin study was conducted for each patient to detect any early anastomotic leaks. Following a normal radiological study, patients were initiated on a liquid diet, which was then advanced to pureed food on the third postoperative day, and a soft diet on the fourth day. For patients in the drain group, the drain was removed on the fifth postoperative day, provided that the drainage volume was less than 50 mL over the preceding 48 hours, in line with departmental protocol The primary outcomes measured in this study were: a) pain levels, assessed using the Visual Analog Scale (VAS) during the first 5 postoperative days, b) postoperative nausea and vomiting (PONV) within the first 5 days, c) initiation of feeding, d) postoperative bowel mobilization, e) patient mobilization, f) length of hospital stay (LOS) Secondary outcomes included: a) mortality, b) surgically related readmissions and c) reoperations This study was conducted in accordance with the principles outlined in the Helsinki Declaration of Human Rights and with the Guidelines of Good Clinical Practice . The final study protocol and the informed consent form for participant inclusion received approval from the Institutional Review Board (IRB). The IRB also conducted regular assessments, as required, to ensure the ongoing compliance with lawful medical practice throughout the trial.
The statistical analysis was performed using the R software (R foundation for Statistical Computing) version 4.3.0 for Windows. Descriptive characteristics for the quantitative data were expressed as median and Quartile 1 (Q1) to Quartile 3 (Q3) range and for completeness reasons the mean ± standard deviation (SD), for the qualitative data was reported the frequency of occurrence and the relevant percentage. Comparisons were preformed between patients with drainage and those without drainage; for the qualitative parameters statistical tests were performed via the chi-square test (and if required a Fisher exact test) and for the arithmetic data (as normality was not possible to be ensured using the Shapiro Wilk test), were applied not parametric tests, specifically the Mann Whitney U test. The significance level (p-value) was set to 0.05, thus statistically significant difference between compared groups was for p<0.05 and all tests were two sided.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain | No intervention | –The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice |
| No drain | Experimental | Procedure: No drain placementThe patients of this arm do not undergo perianastomotic drain placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years old
- Histologically proven EGJ (Siewert II or III) or non-EGJ gastric adenocarcinoma (intestinal, diffuse, or mixed Lauren type)
- Surgical candidates for total gastrectomy plus D2 lymph node dissection
- ECOG performance status 0 or 1
- Signed informed consent from
Key exclusion criteria (7 listed)
- M1 disease
- Other unplanned organ excision
- Massive ascites or cachexia
- Current participation in any other clinical trial
- Severe cardiovascular, respiratory tract, kidney, liver, or psychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drain placementThe need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above | Procedure or surgery | No drain |
Primary outcome
a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)
Time frame: Hospital stay, an average of 5 days
Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups: High pain: VAS score greater than 5 Not high pain: VAS score 5 or less This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain.
Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days
Time frame: Hospital stay, an average of 5 days
Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results
Number of Participants With Delay of Feeding Initiation
Time frame: Hospital stay, an average of 5 days
immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol
Number of Participants With Delay of Postoperative Mobilization
Time frame: Hospital stay, an average of 5 days
immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol.
Length of Hospital Stay
Time frame: Hospital stay, an average of 5 days
immediate effect of drain placement
Day of Postoperative Bowel Mobilization
Time frame: Hospital stay approx 5 days
immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement
3 secondary outcomes
Mortality
Time frame: 30 days
Surgically Related Readmissions
Time frame: 30 days
Reoperations
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Theodorou, Professor study chair
University of Athens
Maria-Malvina Eleftheriou, MD principal investigator
Hippocration General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No drain placement in people with Gastric Cancer, run by THEODOROU DIMITRIOS at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a) Number of Participants With High Pain Levels (Using the Visual Analog Scale) (time frame: Hospital stay, an average of 5 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.