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Colorectal CancerPhase 2SEPRAC2TNCT01262417

Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation

A Phase 2 study testing - use of resorbable membrane Seprafilm and without resorbable barrier (seprafilm) in people with Colorectal Cancer, run by Centre Leon Berard at 17 sites in France.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
- use of resorbable membrane Seprafilm and without resorbable barrier (seprafilm)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
17 sitesFrance
Study dates
Jul 2008to Nov 2010
Phase
Phase 2
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

  • Women and men aged ≥ 18 years
  • Colorectal cancer with synchronous or metachronous hepatic metastases
  • Patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
  • The 2 operations should be scheduled in the same centre
  • The 2 operations should be scheduled at an interval of 1 to 6 months
  • Patient affiliated with social security
  • Patient able to read and write French
  • Written, voluntary, informed consent

Who cannot join

  • Patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
  • Patient with previous major surgery except colorectal surgery for resection of primitive tumour
  • Metastasis removable in one surgical procedure
  • Non resectable metastasis
  • Follow-up impossible for social, geographical, familial or psychological reasons
  • Patient deprived of freedom
  • Patient enrolled in another experimental surgery trial
  • Pregnant or lactating woman

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Hôpital Antoine Béclère

    Clamart

  • CHU Clermont Ferrand

    Clermont-Ferrand

  • Hôpital Beaujon

    Clichy

  • CHU Grenoble

    Grenoble

  • Centre Hospitalier Lyon Sud

    Lyon

  • Centre Léon Bérard

    Lyon

  • Hôpital de La Croix Rousse

    Lyon

  • CHU La conception

    Marseille

  • Institut Paoli Calmettes

    Marseille

  • Centre Val d'Aurelle Paul Lamarque

    Montpellier

  • Centre Alexis Vautrin

    Nancy

  • Hôpital de Brabois CHU

    Nancy

  • CHU Nice-Hôpital de l'Archet II

    Nice

  • Hôpital Cochin

    Paris

  • Hôpital Charles Nicolle - CHU Rouen

    Rouen

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Evaluationof the Efficiency of a Resorbable Barrier Membrane for the Prevention of Abdominal and Peri-hepatic Adhesion in Patients With Colorectal Cancer Requiring Two-stage Surgery for the Resection of Hepatic Metastases

The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.

Eligible patients will be randomly assigned to one of 2 arms:

Read more
  • Seprafilm group (receiving resorbable barrier membrane during the first surgery)
  • No-treatment control group (without seprafilm barrier during the first surgery)

The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.

This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.

A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.

Read the detailed description

The secondary objectives of the study are:

During and after the 1st surgical procedure To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable membrane.

During and after the 2nd surgical procedure

  • To evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description.
  • To evaluate intestinal adhesion (in the small intestine), with quantitative description.
  • To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (in the month following the intervention) in relation with operating procedure.
  • To evaluate post-operative rehabilitation
  • To assess tumour evolution in patients over a period of 3 years after the 2nd surgery.
Being tested
- use of resorbable membrane Seprafilm, without resorbable barrier (seprafilm)
Keywords
colorectal cancer, two stage surgery for the resection of hepatic metastases, resorbable barrier membrane, abdominal and peri-hepatic adhesion
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • - use of resorbable membrane SeprafilmProcedure or surgery

    Also called use of Seprafilm after the resction of hepatic metastases

    use of resorbable membrane during the first surgery for the resection of hepatic metastases, 1 to 4 membranes should be used around the liver

  • without resorbable barrier (seprafilm)Procedure or surgery

    Also called resection of hepatic metastases

    non use of resorbable membrane during the first surgery for the resection of hepatic metastases

Study groups in NCT01262417
Study groupRoleWhat they receive
- Seprafilm groupExperimentalpatients receiving resorbable barrier membrane during the first surgery
Receives: Procedure: - use of resorbable membrane Seprafilm
- No-treatment control groupOtherpatients without seprafilm barrier during the first surgery
Receives: Procedure: without resorbable barrier (seprafilm)

What is being measured

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

  1. abdominal and peri-hepatic adhesion during the second operation

    Measured: Time to liberate liver (t0: incision and t1: liberation)

Secondary outcomes (10)

  1. immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane

    Measured: during the surgery

  2. early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane

    Measured: during post-surgery hospitalization

  3. late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane

    Measured: between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months)

  4. abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description

    Measured: at the beginning of the 2nd surgical procedure

  5. intestinal adhesion (in the small intestine), with quantitative description

    Measured: at the beginning of the second surgical procedure

  6. immediate complications in relation with operating procedure.

    Measured: during the 2nd surgical procedure

  7. early complications (after 2ng operation) in relation with operating procedure.

    Measured: during post-surgery hospitalization

  8. late complications in relation with operating procedure.

    Measured: in the month following the 2nd intervention

  9. post-operative rehabilitation

    Measured: during post-surgery hospitalization

  10. tumour evolution in patients

    Measured: over a period of 3 years after the 2nd surgery

Timeline

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

  1. First posted17 Dec 2010 (estimated)
  2. Study startJul 2008
  3. Primary completionNov 2010

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262417
Sponsor's protocol ID
SEPRAC2T
Acronym
SEPRAC2T
Status last verified
May 2010
First submitted
15 Dec 2010
Last updated
17 Dec 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Weibel MA, Majno G. Peritoneal adhesions and their relation to abdominal surgery. A postmortem study. Am J Surg. 1973 Sep;126(3):345-53. doi: 10.1016/s0002-9610(73)80123-0. No abstract available.

    PubMed 4580750

  • Adam R, Laurent A, Azoulay D, Castaing D, Bismuth H. Two-stage hepatectomy: A planned strategy to treat irresectable liver tumors. Ann Surg. 2000 Dec;232(6):777-85. doi: 10.1097/00000658-200012000-00006.

    PubMed 11088072

  • Jaeck D, Oussoultzoglou E, Rosso E, Greget M, Weber JC, Bachellier P. A two-stage hepatectomy procedure combined with portal vein embolization to achieve curative resection for initially unresectable multiple and bilobar colorectal liver metastases. Ann Surg. 2004 Dec;240(6):1037-49; discussion 1049-51. doi: 10.1097/01.sla.0000145965.86383.89.

    PubMed 15570209

  • Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80. doi: 10.1016/S0140-6736(98)09337-4.

    PubMed 10232313

  • Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. doi: 10.1007/BF02237135.

    PubMed 10211502

  • Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.

    PubMed 11727865

  • Ray NF, Denton WG, Thamer M, Henderson SC, Perry S. Abdominal adhesiolysis: inpatient care and expenditures in the United States in 1994. J Am Coll Surg. 1998 Jan;186(1):1-9. doi: 10.1016/s1072-7515(97)00127-0.

    PubMed 9449594

  • Lower AM, Hawthorn RJ, Ellis H, O'Brien F, Buchan S, Crowe AM. The impact of adhesions on hospital readmissions over ten years after 8849 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. BJOG. 2000 Jul;107(7):855-62. doi: 10.1111/j.1471-0528.2000.tb11083.x.

    PubMed 10901556

  • Lower AM, Hawthorn RJ, Clark D, Boyd JH, Finlayson AR, Knight AD, Crowe AM; Surgical and Clinical Research (SCAR) Group. Adhesion-related readmissions following gynaecological laparoscopy or laparotomy in Scotland: an epidemiological study of 24 046 patients. Hum Reprod. 2004 Aug;19(8):1877-85. doi: 10.1093/humrep/deh321. Epub 2004 Jun 3.

    PubMed 15178659

  • Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.

    PubMed 11391142

  • Parker MC. Epidemiology of adhesions: the burden. Hosp Med. 2004 Jun;65(6):330-6. doi: 10.12968/hosp.2004.65.6.13729.

    PubMed 15222206

  • Bristow RE, Montz FJ. Prevention of adhesion formation after radical oophorectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier. Gynecol Oncol. 2005 Nov;99(2):301-8. doi: 10.1016/j.ygyno.2005.06.057. Epub 2005 Aug 8.

    PubMed 16085295

  • Bristow RE, Santillan A, Diaz-Montes TP, Gardner GJ, Giuntoli RL 2nd, Peeler ST. Prevention of adhesion formation after radical hysterectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier: a cost-effectiveness analysis. Gynecol Oncol. 2007 Mar;104(3):739-46. doi: 10.1016/j.ygyno.2006.09.029. Epub 2006 Nov 13.

    PubMed 17097723

  • Duron JJ. [Post-operative bowel obstruction. Part 2: Mechanical post-operative small bowel obstruction by bands and adhesions]. J Chir (Paris). 2003 Dec;140(6):325-34. French.

    PubMed 14978440

  • Duron JJ. [Post-operative bowel obstruction. Part 1: Intraperitoneal bands and adhesions--causes and prevention]. J Chir (Paris). 2003 Sep;140(4):211-9. French.

    PubMed 13679770

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing - use of resorbable membrane Seprafilm and without resorbable barrier (seprafilm) in people with Colorectal Cancer, run by Centre Leon Berard at 17 sites in France.

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 8 inclusion and 8 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 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

abdominal and peri-hepatic adhesion during the second operation (time frame: Time to liberate liver (t0: incision and t1: liberation)). 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 NCT01262417, which also lists 34 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 17 Dec 2010.

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