AzTrials
AzTrials

Gastric CancerADiGeNCT04227951

Gastrectomy With or Without Drainage (ADiGe)?

A study testing Avoid drain placement and Drain placement in people with Gastric Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 11 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in… 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?
Avoid drain placement and Drain placement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
11 sitesItaly
Study dates
17 Dec 2019to 29 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number
  • esophageal involvement <= 2 cm
  • patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
  • open, hybrid, laparoscopic or robotic approach
  • all types of anastomosis (circular stapled, linear stapled, hand sewn)

Who cannot join

  • refuse to sign informed consent
  • age <18
  • Heart failure New York Heart Association (NYHA) class IV
  • severe liver disease (Child >= 7)
  • pregnancy
  • metastatic disease
Show all 14Show fewer
  • emergency surgery
  • palliative surgery
  • operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy)
  • lymphnodal dissection <D1
  • reconstruction different from Roux-en-Y or Billroth II
  • multiple organ resections (except for cholecystectomy)
  • gastric cancer with duodenal involvement
  • intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Italy11 sites

  • Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica

    Bergamo

  • Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale

    Bologna

  • Ospedale di Cremona

    Cremona

  • Ospedale Morgagni di Forlì - Chirurgia generale

    Forlì, Forlì-Cesena

  • Ospedale San Raffaele - Chirurgia Gastroenterologica -

    Milan

  • ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva

    Milan

  • Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza

    Modena

  • Ospedale Federico II di Napoli- Chirurgia Generale

    Naples

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale

    Orbassano, Torino

  • Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale

    Parma

  • Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco

    Verona, 37124

Other trials in Italy

About this study

Official title: A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)

Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.

Conditions
Gastric Cancer
Being tested
Avoid drain placement, Drain placement
Keywords
Gastrectomy, Drain, Drainage
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avoid drain placementDevice

    In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.

  • Drain placementDevice

    In Drain arm (sham comparator) an abdominal drain is inserted in the abdomen from the right flank, passing below the liver (close to the duodenal stump) with the apex behind the esophago-jejunal (in total gastrectomy) or gastro-jejunal (in subtotal gastrectomy) anastomosis.

Study groups in NCT04227951
Study groupRoleWhat they receive
DrainSham comparatorParticipants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.
Receives: Device: Drain placement
No DrainExperimentalParticipants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.
Receives: Device: Avoid drain placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 day reoperation AND/OR additional drain placement

    Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)

    Measured: 30 days after the operation

Secondary outcomes (4)

  1. Overall mortality

    Measured: 90 days after the operation

  2. Overall morbidity

    Complications are classified according to International consensus on a complications list after gastrectomy for cancer - Baiocchi et Al, Gastric Cancer, 2019 and stratified according to Clavien-Dindo classification.

    Measured: 30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization

  3. Length of hospital stay

    Measured: From the day of operation until discharge (home or other facilities) or death for any cause whichever came first, assessed up to 100 months.

  4. Drain related complications

    Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded

    Measured: From the day of operation until drain removal up to 90 days after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2020
  2. Study start17 Dec 2019
  3. Primary completion28 Jan 2023
  4. Study completion29 Mar 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227951
Sponsor's protocol ID
2245CESC
Acronym
ADiGe
Status last verified
Nov 2023
First submitted
8 Jan 2020
Last updated
30 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained through this study may be provided to qualified researchers with academic interest in abdominal surgery. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Publications

  • Wang Z, Chen J, Su K, Dong Z. Abdominal drainage versus no drainage post-gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2015 May 11;2015(5):CD008788. doi: 10.1002/14651858.CD008788.pub3.

    PubMed 25961741

  • Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.

    PubMed 25047143

  • Schots JPM, Luyer MDP, Nieuwenhuijzen GAP. Abdominal Drainage and Amylase Measurement for Detection of Leakage After Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2018 Jul;22(7):1163-1170. doi: 10.1007/s11605-018-3789-7. Epub 2018 May 7.

    PubMed 29736661

  • Dann GC, Squires MH 3rd, Postlewait LM, Kooby DA, Poultsides GA, Weber SM, Bloomston M, Fields RC, Pawlik TM, Votanopoulos KI, Schmidt CR, Ejaz A, Acher AW, Worhunsky DJ, Saunders N, Swords DS, Jin LX, Cho CS, Winslow ER, Russell MC, Staley CA, Maithel SK, Cardona K. Value of Peritoneal Drain Placement After Total Gastrectomy for Gastric Adenocarcinoma: A Multi-institutional Analysis from the US Gastric Cancer Collaborative. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S888-97. doi: 10.1245/s10434-015-4636-7. Epub 2015 May 29.

    PubMed 26023037

  • Hirahara N, Matsubara T, Hayashi H, Takai K, Fujii Y, Tajima Y. Significance of prophylactic intra-abdominal drain placement after laparoscopic distal gastrectomy for gastric cancer. World J Surg Oncol. 2015 May 12;13:181. doi: 10.1186/s12957-015-0591-9.

    PubMed 25962503

  • Lee J, Choi YY, An JY, Seo SH, Kim DW, Seo YB, Nakagawa M, Li S, Cheong JH, Hyung WJ, Noh SH. Do All Patients Require Prophylactic Drainage After Gastrectomy for Gastric Cancer? The Experience of a High-Volume Center. Ann Surg Oncol. 2015 Nov;22(12):3929-37. doi: 10.1245/s10434-015-4521-4. Epub 2015 Apr 7.

    PubMed 25845430

  • Weindelmayer J, Mengardo V, Ascari F, Baiocchi GL, Casadei R, De Palma GD, De Pascale S, Elmore U, Ferrari GC, Framarini M, Gelmini R, Gualtierotti M, Marchesi F, Milone M, Puca L, Reddavid R, Rosati R, Solaini L, Torroni L, Totaro L, Veltri A, Verlato G, de Manzoni G; Italian Research Group for Gastric Cancer (GIRCG). Prophylactic Drain Placement and Postoperative Invasive Procedures After Gastrectomy: The Abdominal Drain After Gastrectomy (ADIGE) Randomized Clinical Trial. JAMA Surg. 2025 Feb 1;160(2):135-143. doi: 10.1001/jamasurg.2024.5227.

    PubMed 39602143

  • Weindelmayer J, Mengardo V, Veltri A, Baiocchi GL, Giacopuzzi S, Verlato G, de Manzoni G; Italian Research Group for Gastric Cancer (GIRCG). Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial. Trials. 2021 Feb 17;22(1):152. doi: 10.1186/s13063-021-05102-1.

    PubMed 33596959

Questions about this trial

What is this clinical trial studying?

A study testing Avoid drain placement and Drain placement in people with Gastric Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 11 sites in Italy.

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 5 inclusion and 14 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

30 day reoperation AND/OR additional drain placement (time frame: 30 days after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227951, which also lists 8 linked publications.

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 30 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Gastrectomy With or Without Drainage (ADiGe)? | AzTrials