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Esophageal NeoplasmsNCT01139229

Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

A study testing hybrid everted esophagogastric anastomosis, the conventional hand-sewn anastomosis and a stapled anastomosis in people with Esophageal Neoplasms and Surgical Stomas, run by Sichuan University.

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 investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications. Read more about this study

Who is it for?
Any age
Conditions the study is for
Esophageal Neoplasms, Surgical Stomas
What is being tested?
hybrid everted esophagogastric anastomosis, the conventional hand-sewn anastomosis and a stapled anastomosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
No sites listed yet
Study dates
Nov 2007to Sep 2008
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • pathologically diagnosed esophageal neoplasms
  • undergoing the Esophagogastrostomy

Who cannot join

  • the patients with previous the upper gastrointestinal tract surgery
  • the esophageal carcinoma patients with previous neoadjuvant chemotherapy
  • the esophageal carcinoma complicated other esophagogastric diseases

About this study

Official title: Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.

Read the detailed description

This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram), analyzed by intention-to-treat.

Being tested
hybrid everted esophagogastric anastomosis, the conventional hand-sewn anastomosis, a stapled anastomosis
Keywords
Esophagogastrostomy, Circular everted anastomosis, Side-side anastomosis, Randomized clinical trial
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • hybrid everted esophagogastric anastomosisOther

    Also called no other names

  • the conventional hand-sewn anastomosisOther

    Also called no other names

  • a stapled anastomosisOther

    Also called no other names

Study groups in NCT01139229
Study groupRoleWhat they receive
HE groupOtherNot described
Receives: Other: hybrid everted esophagogastric anastomosis
HS groupOtherNot described
Receives: Other: the conventional hand-sewn anastomosis
SA groupOtherNot described
Receives: Other: a stapled anastomosis

What is being measured

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

  1. the incidence of anastomotic stricture

    the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram

    Measured: three months

Secondary outcomes (3)

  1. The grades of dysphagia

    0:No dysphagia on solid diet

    1. dysphagia on solid diet
    2. dyspahgia on semi-solid diet
    3. dysphagia on fluid diet
    4. dysphagia with water swallowing

    Measured: three months

  2. the grades of acid regurgitation

    0:no reflux on semi-supine position

    1. postprandial reflux on semi-supine position
    2. reflux with empty stomatch on semi-supine position
    3. postprandial reflux on upright position
    4. reflux with empty stomach on upright positino

    Measured: three months

  3. the clinicopathological parameters in relation to postoperative complications

    Measured: three months

Timeline

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

  1. First posted8 Jun 2010 (estimated)
  2. Study startNov 2007
  3. Primary completionNov 2007
  4. Study completionSep 2008

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
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01139229
Sponsor's protocol ID
WCH20070901
Status last verified
Mar 2010
First submitted
3 Jun 2010
Last updated
8 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • Law S, Fok M, Chu KM, Wong J. Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer: a prospective randomized controlled trial. Ann Surg. 1997 Aug;226(2):169-73. doi: 10.1097/00000658-199708000-00008.

    PubMed 9296510

  • Behzadi A, Nichols FC, Cassivi SD, Deschamps C, Allen MS, Pairolero PC. Esophagogastrectomy: the influence of stapled versus hand-sewn anastomosis on outcome. J Gastrointest Surg. 2005 Nov;9(8):1031-40; discussion 1040-2. doi: 10.1016/j.gassur.2005.06.025.

    PubMed 16269373

  • Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. doi: 10.1016/j.explore.2004.11.001.

    PubMed 16791967

  • Zhu ZJ, Zhao YF, Chen LQ, Hu Y, Liu LX, Wang Y, Kou YL. Clinical application of layered anastomosis during esophagogastrostomy. World J Surg. 2008 Apr;32(4):583-8. doi: 10.1007/s00268-007-9396-5.

    PubMed 18210181

  • Laterza E, de' Manzoni G, Veraldi GF, Guglielmi A, Tedesco P, Cordiano C. Manual compared with mechanical cervical oesophagogastric anastomosis: a randomised trial. Eur J Surg. 1999 Nov;165(11):1051-4. doi: 10.1080/110241599750007883.

    PubMed 10595609

  • Wang WP, Gao Q, Wang KN, Shi H, Chen LQ. A prospective randomized controlled trial of semi-mechanical versus hand-sewn or circular stapled esophagogastrostomy for prevention of anastomotic stricture. World J Surg. 2013 May;37(5):1043-50. doi: 10.1007/s00268-013-1932-x.

    PubMed 23381675

Questions about this trial

What is this clinical trial studying?

A study testing hybrid everted esophagogastric anastomosis, the conventional hand-sewn anastomosis and a stapled anastomosis in people with Esophageal Neoplasms and Surgical Stomas, run by Sichuan University.

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 2 inclusion and 3 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 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

the incidence of anastomotic stricture (time frame: three months). 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 NCT01139229, which also lists 6 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 8 Jun 2010.

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