Trial Comparing Side-to-Side Stapled and Hand-sewn Esophagogastric Anastomosis in Neck
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00497549|
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : May 10, 2011
|First Submitted Date ICMJE||July 5, 2007|
|First Posted Date ICMJE||July 6, 2007|
|Last Update Posted Date||May 10, 2011|
|Study Start Date ICMJE||July 2004|
|Actual Primary Completion Date||January 2010 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Anastomotic leakage defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound. [ Time Frame: within 7 days ]
It was defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound
|Original Primary Outcome Measures ICMJE
||Anastomotic leakage defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound.|
|Change History||Complete list of historical versions of study NCT00497549 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE
||Anastomotic stricture defined as failure to pass the esophagoscope through the anastomosis or anastomotic narrowing requiring dilatation to relieve dysphagia.|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Trial Comparing Side-to-Side Stapled and Hand-sewn Esophagogastric Anastomosis in Neck|
|Official Title ICMJE||Prospective Randomized Controlled Trial Comparing Side to Side Stapled and Hand Sewn Esophagogastric Anastomosis in the Neck|
|Brief Summary||Carcinoma esophagus is a common cause of dysphagia. Once dysphagia occurs, a majority of the tumours are advanced. Most of them would require some form of treatments for control of dysphagia and to improve the quality of life. Surgery is the only hope for cure. It requires complete removal of the esophagus. After removal of the esophagus, the stomach can be used as a substitute for the esophagus. Anastomosis can be done in the neck either by a hand-sewn or by a stapled anastomosis. The anastomotic leak rates reported in studies comparing hand-sewn with stapled anastomosis are variable. Many non-randomized studies have reported leak rate as low as 5% with stapled technique. However, the stricture rate is higher in the stapled group. There is no randomized study comparing hand-sewn anastomosis with side-to-side stapled anastomosis. Hence, the investigators planned a randomized trial comparing the anastomotic sequelae after hand-sewn anastomosis with stapled anastomosis in the neck.|
Side-to-side stapled anastomosis will decrease anastomotic leak rate by 15% compared to hand sewn technique in cervical esophagogastric anastomosis
Following esophagectomy or esophageal bypass, restoration of continuity by gastric interposition with cervical esophagogastric anastomosis (CEGA) can be done either by a hand-sewn or stapled anastomosis. Regardless of the surgical approach, decreasing anastomotic complications is essential for minimizing early morbidity and improving long-term functional results and quality of life. Cervical esophagogastric anastomosis almost eliminates the risk of postoperative mediastinitis associated with anastomotic leaks. Further, 98% of CEGA leaks can be managed successfully with local wound care (1), and less than 2% are associated with serious complications such as gastric tip necrosis, cervical vertebral osteomyelitis, epidural abscess and tracheogastroesophageal fistula, etc (2). Though early complications of CEGA are less, the long-term sequelae such as anastomotic stricture occur in nearly half the patients with an anastomotic leak. The need for life long esophageal dilatation negates the benefit of an operation intended to relieve dysphagia. The cause of anastomotic dehiscence in CEGA is possibly multifactorial (3,4) with both local tissue and systemic factors are being implicated. As the esophagus has no serosa, its longitudinal muscles hold sutures poorly and the awkward surgical exposure, possibly contribute to the higher anastomotic leak rates. Surgical technique is thus likely to play an important role. The incidence of CEGA leakage with hand sewn has been reported from 15% to 25% (5). While the stapled anastomosis is considered to be more expedient, less traumatic to tissues, with lower leak rates and associated with less mortality and morbidity, they are criticized for increased cost and high stricture rates. Most reports prior to 2000 showed identical leak rates in patients having a hand-sewn or stapled anastomosis with higher stricture rate in the stapled group (6-8). With recent technical refinements the CEGA has been performed in side-to-side manner using the Auto-Suture Endo-GIA 30-3.5 stapler. Following side to side anastomosis the leak rates have been reported to be less than 5%, with lower incidence of anastomotic stricture after leak and improved satisfaction in swallowing compared to hand sewn technique (9). These studies were retrospective and demanded a randomized trial to confirm the results. We therefore planned a randomized trial comparing the anastomotic sequelae after hand-sewn anastomosis with mechanical stapled side-to-side anastomosis
To compare the rates of anastomotic leaks and postoperative benign stricture after CEGA done by hand-sewn (end-to-side) technique or by linear stapled anastomosis (side-to-side) technique.
PATIENTS AND METHODS:
All the patients who attended outpatient department of GI Surgery with complaints of dysphagia will be evaluated for esophageal disorder. After confirming the diagnosis of esophageal cancer and decision of esophagectomy, patients will be included in our study.
Inclusion criteria i Any patient with resectable carcinoma of the mid or lower thoracic esophagus and gastro-esophageal junction. ii Benign esophageal lesion where esophageal resection was beneficial and feasible.
Exclusion criteria i Patients who had upper thoracic or cervical esophageal carcinoma ii Unresectable lesions (T4/M1) iii Prior gastric surgery iv Poor performance status (ECOG 3,4) Sample size calculation The number of patients to be included was calculated to be 87 patients in each group based on the assumption that anastomotic leak rate will be reduced to 5% using side-to-side stapled anastomosis. The sample size was calculated by the formula for a power of 80% and alpha error of 0.05.
They will be randomly divided into two groups using computer generated random numbers.
Group A Hand sewn anastomosis; Group B Stapled anastomosis Written informed consent will be obtained from each patient before entry into the study.
Diagnostic work up and preoperative preparation The diagnostic work-up will include barium swallow, upper gastrointestinal (UGI) endoscopy and biopsy (where malignancy was suspected), hypopharyngoscopy (for corrosive stricture of esophagus), as well as haemogram, serum chemistry, liver function tests, ECG, chest x-ray and pulmonary function tests. In the malignant group, preoperative imaging will also include computed tomography (CT) scan from the neck to the upper abdomen including the liver and celiac axis. Preoperative nutrition will be maintained and if required a ryle tube or feeding jejunostomy will be done. Incentive spirometry, steam inhalation, bronchodilators and antibiotics will be used to improve the pulmonary status as required.
At surgery, the operative procedures, time taken for anastomosis and total operating time will be recorded. After surgery, patients will be assessed for anastomotic leakage by a radiographic contrast (gastrografin) study to be performed on seventh postoperative day. Anastomotic leakage will be defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound. Other complications, including cardiopulmonary morbidity, septic complications, duration of hospital stay after surgery and operative mortality will also be studied. Operative mortality included all patients who will die within 30 days of the procedure or during the same hospital admission. Anastomotic stricture will be defined as failure to pass the esophagoscope through the anastomosis or anastomotic narrowing requiring dilatation to relieve dysphagia.
The surgical approach will be either transhiatal or transthoracic esophagectomy. The gastric conduit will be prepared based on the right gastric and right gastroepiploic vessels and pyloromyotomy and pyloroplasty will not performed except in patients with corrosive strictures. Finger dilatation of pylorus will be done when required. The conduit will be prepared using 75-mm linear cutter. The stomach will be brought up into the neck through either the retrosternal or posterior mediastinal route. The CEGA will be done by a side-to-side stapled or end-to-side hand-sewn method. Chest tubes (32F) will be inserted bilaterally to take care of any breach in the pleura. Feeding jejunostomy (Witzel's type) with 12F Malecot's catheter will be done in all patients. The neck wound will be closed loosely with interrupted 3-0 vicryl sutures over a 14F suction drain and the skin will be approximated with skin staplers.
Hand-sewn anastomosis: A proper site on the anterior wall of stomach away from the stapled line approximately 2 cm below the highest point of the gastric conduit will be anastamosed to esophagus Posterior interrupted seromuscular sutures will be taken with 3-0 silk. The stomach will then be opened transversely (2.5 to 3 cm long). Interrupted stitches with full thickness of the stomach and esophagus will be placed to achieve mucosa to mucosa approximation. A 16F nasogastric tube will then be placed across the anastomosis into the intrathoracic stomach. The anterior wall of the anastomosis will be completed in a manner similar to posterior wall.
Stapled anastomosis: At least 5 cm of the mobilized stomach will be placed in the neck. Three interrupted seromuscular sutures will be taken between the posterior wall of the esophagus and anterior wall of stomach well away from the gastric staple line. A 1.5 cm gastrotomy will be made. Two stay sutures will then be taken, one at the anterior corner of the esophagus and another between the posterior corner of esophagus and the middle of the gastrotomy. These stay sutures will be retracted downwards as the stapler device (using Endopath, EZ45 Endoscopic Linear Cutter) will be introduced, the thinner portion into the stomach and the thicker staple-bearing portion into the esophagus. The staple cartridge will then be rotated so that the posterior wall of the esophagus and the anterior wall of the stomach will align in a parallel manner, keeping the site of the anastomosis well away from the gastric staple suture line and fire the stapler. A 16F nasogastric tube will be placed across the anastomosis into the intrathoracic stomach, and the anterior edges of the gastrotomy and open esophagus will be approximated in two layers with interrupted 3-0 silk.
Postoperative management: The nasogastric tube will be removed on the 3rd postoperative day. Jejunostomy trial feed will be started intestinal activity will appear. If there is no obvious leak, bedside test feeding with water will be done on the 5th postoperative day. If bedside test feeding shows no leak, oral feeding will be started gradually with water, banana, curds and soft diet. A contrast study will be done on the 7th postoperative day unless there is an obvious anastomotic leak. The neck drain will be removed after the contrast study. If a leak is identified, the cervical wound will be opened to establish external drainage of any cervical abscess and anastomotic fistulae. Regular dressing with normal saline soaked gauze will be done. If there is no clinical leak but the contrast study shows a contained leak (type 1 leak), patients will be managed conservatively without opening the cervical wound.
All patients will be followed one week after discharge and at 3-month intervals for the first two years. Routine clinical examination, hemogram and liver function tests will be done in all patients. Dysphagia will be assessed with barium swallow and esophagoscopy. Anastomotic strictures will be dilated with endoscopic or by a Foley catheter balloon (This technique has been adapted for home based self dilatation) (10).
Continuous variables will be reported as Mean with Standard Error of Mean (SEM). Categorical variables will be reported as proportions. Student's t test, Chi-square tests and Fisher's exact test where appropriate will be used for comparison between groups. A p value of 0.05 or less will be regarded as significant.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Esophageal Cancer|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Actual Study Completion Date||December 2010|
|Actual Primary Completion Date||January 2010 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||India|
|Removed Location Countries|
|NCT Number ICMJE||NCT00497549|
|Other Study ID Numbers ICMJE||GIS1/2004|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Sundeep Singh Saluja, Department of G I Surgery, AIIMS|
|Study Sponsor ICMJE||All India Institute of Medical Sciences, New Delhi|
|Collaborators ICMJE||Not Provided|
|PRS Account||All India Institute of Medical Sciences, New Delhi|
|Verification Date||April 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP